Safety and Immunogenicity in Dose-Ranging and Formulation-Finding Meningococcal B (MenB) Vaccine Study in 2-month-old Infants
Sponsor
Novartis Vaccines (Industry)
Overall Status
Completed
CT.gov ID
NCT00937521
Collaborator
(none)
1,507
38
8
31
39.7
1.3
Study Details
Study Description
Brief Summary
This study is aimed at assessing the safety and immunogenicity of different doses and formulations of a new Novartis Meningococcal B Recombinant Vaccine.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
1507 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
A Phase 2 Partially Observer-Blind Randomized Controlled Multicenter Dose-Ranging and Formulation-Finding Study of a New Novartis Meningococcal B Recombinant Vaccine Evaluating the Safety and Immunogenicity When Given Concomitantly With Routine Vaccines in 2-month-old Infants
Study Start Date
:
Jul 1, 2009
Actual Primary Completion Date
:
Nov 1, 2010
Actual Study Completion Date
:
Feb 1, 2012
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: 1 Vaccine candidate formulation I |
Biological: Meningococcal B vaccine
Vaccine candidate formulation I
|
| Other: 2 Vaccine candidate formulation II |
Biological: Meningococcal B vaccine
Vaccine candidate formulation II
|
| Other: 3 Vaccine candidate formulation III |
Biological: Meningococcal B vaccine
Vaccine candidate formulation III
|
| Other: 4 Vaccine candidate formulation IV |
Biological: Meningococcal B vaccine
Vaccine candidate formulation IV
|
| Other: 5 Vaccine candidate formulation V |
Biological: Meningococcal B vaccine
Vaccine candidate formulation V
|
| Other: 6 Vaccine candidate formulation VI |
Biological: Meningococcal B vaccine
Vaccine candidate formulation VI
|
| Other: 7 Control |
Biological: Control
Control
|
| Other: 8 Vaccine candidate formulation I with antipyretic |
Biological: Meningococcal B vaccine with antipyretic
Vaccine candidate formulation I with antipyretic
|
Outcome Measures
Primary Outcome Measures
- Percentages of Subjects With Serum Bactericidal Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination [At baseline (pre-vaccination) and 30 days after the third vaccination.]
To assess the immunogenicity of seven different formulations of 4CMenB (groups I-VI and VIII) given to healthy infants at 2,3 and 4 months of age as measured by percentages of subjects with serum bactericidal activity (SBA) titer≥1:5 against 44/76-SL, 5/99 and NZ98/254 reference strains, at 1 month after the third vaccination.. The analysis was done on the Per Protocol Primary Population at one month after third injection.
- Number of Subjects With Fever ≥ 38.5 °C (Rectal Temperature) Within 3 Days (Day 1-3) After First Vaccination [Day 1 to day 3 after first vaccination.]
To assess if any of six different formulations of vaccine groups (Group II to Group VI, Group VIII) reduced the incidence of fever >=38.5C (rectal) occurring within three days (day 1-day3) following first vaccination. The analysis was done on the Safety Population.
Secondary Outcome Measures
- Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) [At baseline (pre-vaccination), 30 days after the third vaccination, at booster Baseline and at booster vaccination (12 months of age)]
ToTo assess the immune response of seven different formulations of meningococcal multi-component recombinant, adsorbed vaccine (rMenB+OMV NZ or rMenB (no OMV)) in healthy toddlers as measured by SBA geometric mean titers (GMTs) at: One month after third vaccination. One month after booster vaccination (Men B at 12 months of age).
- Geometric Mean Bactericidal Titers,One Month After Primary and Booster Vaccination (Men B at 12 Months of Age) [At Baseline (pre-vaccination), at 30 days after the third vaccination, at booster Baseline, at 30 days]
To compare the antibody response of meningococcal multi-component recombinant, adsorbed vaccine (formulation I vs. formulation VIII) and of routine infant vaccine given with or without prophylactic administration of paracetamol medication in healthy toddlers.
- Geometric Mean Ratios, One Month After Primary and Booster Vaccination (Men B at 12 Months of Age) [After the third and the booster vaccination.]
To compare the antibody response between meningococcal multi-component recombinant adsorbed vaccine (formulation I) and routine infant vaccine group along with meningococcal multi-component recombinant adsorbed vaccine with prophylactic administration of paracetamol medication as measured by Geometric Mean Ratios (GMRs).
- Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (Pre-fourth Dose) [12 months (pre-fourth vaccination)]
To assess the persistence of bactericidal antibodies at 12 months of age after primary vaccination - three doses of one of the seven different formulations of rMenB+OMV NZ or rMenB (no OMV) (Group I-VI and VIII) and rMenB+OMV NZ with paracetamol medication.
- Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (One Month-post Fourth Dose) [1 month after fourth vaccination]
To assess if any of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (groups I-VI and VIII) induced sufficient immune response when given to healthy toddlers at 12 months of age, as measured by percentage of subjects with SBA titer ≥ 1:5, at 1 month after the fourth vaccination.
- Geometric Mean Bactericidal Titers, After Primary and Booster Vaccinations (Men B at 12 Months of Age) [At 13 months]
To assess the induction of immunological memory of three doses of meningococcal multi-component recombinant, adsorbed vaccine by comparing the serum bactericidal antibodies Geometric Mean Bactericidal Titers (GMTs) response in healthy toddlers administered the fourth dose at 12 months of age to the response in meningococcal B vaccine naive toddlers (Group VII) receiving the first dose of meningococcal multi-component recombinant, adsorbed vaccine at 12 months of age.
- Percentage of Subjects With hSBA ≥1:5, First Dose of Meningococcal B Vaccine (One Month After Booster) [1 month after booster]
To assess the immune response of first dose of meningococcal multi-component recombinant, adsorbed vaccine given at 12 months of age to toddlers who previously received three doses of MenC-CRM197 vaccine as infants (group VII).
- Safety and Reactogenicity of Study Vaccines Within 7 Days After Second and Third Vaccination [Day 1 through day 7 after second and third vaccination.]
To assess if any of six different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (Group II to VI, Group VIII) reduced the incidence of fever ≥ 38.5ºC (rectal) occurring within 3 days (day 1-3) following second and third vaccination and 7 days (day 1-7) following each vaccination as compared to rMenB+OMV NZ (Group I).
- Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination [Day 1 through day 7 after each vaccination.]
To assess the safety and tolerability of each of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (group I to VI, group VIII) in terms of number of subjects reporting solicited local reactions within 7 days (day 1-7) after each vaccination.
- Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination [Day 1 through day 7 after each vaccination.]
To assess the safety and tolerability of each of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (group I to VI, group VIII) in terms of number of subjects reporting solicited systemic reactions within 7 days (day 1-7) after each vaccination.
- Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination [Day 1 through day 7 after each vaccination.]
To assess the safety and tolerability of each of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (group I to VI, group VIII) in terms of number of subjects reporting unsolicited Adverse Events (AEs), serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal (throughout the study period) within 7 days (day 1-7) after each vaccination.
- Number of Subjects With Severe Adverse Events and Adverse Events Necessitating a Medical Office or Emergency Room (ER) Visit and/or Resulting in Premature Withdrawal of the Subject From the Study, Throughout the Study Period. [Overall study period.]
To assess the safety and tolerability of each of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (group I to VI, group VIII) in terms of number of subjects reporting Severe Adverse Events (SAEs) and Adverse Events (AEs) necessitating a medical office or Emergency Room (ER) visit and/or resulting in premature withdrawal of the subject from the study, throughout the study period.
- Number of Subjects With Local and Systemic Reactions Within 7 Days (Day 1-7) After Second rMenB+OMV NZ Vaccination in MenC Group [Day 1 through day 7 at 13 months age.]
To assess the safety and tolerability of two doses of rMenB+OMV NZ vaccine (Group VII) given at 12 and 13 months of age to toddlers who previously received three doses of Menjugate as infants.
Eligibility Criteria
Criteria
Ages Eligible for Study:
55 Days
to 89 Days
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Healthy 2-month old infants (55-89 days, inclusive), born after full term pregnancy, gestational age ≥ 37 weeks and a birth weight ≥ 2.5 kg
-
Available for all the visits scheduled in the study and for whom a parent/legal guardian is willing/able to comply with all protocol requirements
Exclusion Criteria:
-
Any meningococcal B or C vaccine administration
-
Prior vaccination with any Diphtheria, Tetanus, Pertussis (acellular or whole cell), Polio (either Inactivated or Oral), Haemophilus influenzae type b (Hib), and Pneumococcal antigens;
-
Any ascertained or suspected disease caused by N. meningitidis
-
Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis
-
History of severe allergic reaction after previous vaccinations
-
Recent significant acute or chronic infection
-
Oral or parenteral antibiotic treatment in the 7 days prior to the scheduled blood draw;
-
Any serious chronic or progressive disease according to the judgment of the investigator (e.g., neoplasm, diabetes mellitus Type I, cardiac disease, hepatic disease, progressive neurological disease or seizure, either associated with fever or as part of an underlying neurological disorder or syndrome, autoimmune disease, HIV infection or AIDS, or blood dyscrasias or diathesis, signs of cardiac or renal failure or severe malnutrition)
-
Any impairment/alteration of the immune system resulting from (for example):
-
Receipt of any immunosuppressive therapy at any time since birth
-
Receipt of immunostimulants at any time since birth
-
Use of systemic corticosteroids or chronic use of inhaled high-potency corticosteroids at any time since birth
-
Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation
-
Participation in another clinical trial
-
Family members and household members of research staff
-
History of seizure
-
Any contraindication to paracetamol
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Privado de Córdoba CMC SA | Naciones Unidas 346 | Cordoba | Argentina | X5016KHE |
| 2 | Universidad de Chile, Av Independencia 1027 | Comuna de Independencia | Santiago | Chile | |
| 3 | Consultorio Manuel Bustos | Lo Cruzat 486, Quilicura | Santiago | Chile | |
| 4 | Samostatna ordinace praktickeho lekare pro deti a dorost | O. Kubina 17 | Boskovice | Czech Republic | 680 01 |
| 5 | Samostatna ordinace praktickeho lekare pro deti a dorost | Neklez 3 | Brno | Czech Republic | 628 00 |
| 6 | Samostatna ordinace praktickeho lekare pro deti a dorost | Pernštýnská 127/l | Chlumec nad Cidlinou | Czech Republic | 503 51 |
| 7 | Zdravotní středisko | Vaclavska 4186 | Chomutov | Czech Republic | 430 03 |
| 8 | Nemocnice Decin, Detske oddělení | U nemocnice 1 | Děčín | Czech Republic | 405 01 |
| 9 | Fakulta vojenskeho zdravotnictvi UO | Trebešská 1575 | Hradec Králové | Czech Republic | 50001 |
| 10 | Samostatna ordinace praktickeho lekare pro deti a dorost | Masarykova 389 | Humpolec | Czech Republic | 396 01 |
| 11 | Samostatna ordinace praktickeho lekare pro deti a dorost | Ruských legii 352 | Jindřichův Hradec | Czech Republic | 377 01 |
| 12 | Samostatna ordinace praktickeho lekare pro deti a dorost | Hrnčířská 1401 | Lipník nad Bečvou | Czech Republic | 751 31 |
| 13 | Oblastni nemocnice Nachod, Destske oddělení | Purkyňova 446 | Náchod | Czech Republic | 547 01 |
| 14 | Samostatna ordinace praktickeho lekare pro deti a dorost | U lékárny 306 | Odolena Voda | Czech Republic | 250 70 |
| 15 | Prakticky lekar pro deti a dorost | Dvouletky 54 | Ostrava | Czech Republic | 700 30 |
| 16 | KHS Ostrava, Protiepidemické oddělení | Na Bělidle 7 | Ostrava | Czech Republic | 702 00 |
| 17 | Nemocnice Pardubice, Destske odděleni | Kyjevská 44 | Pardubice | Czech Republic | 532 03 |
| 18 | Fakultni nemocnice Bory | E. Beneše 13 | Plzeň | Czech Republic | 305 99 |
| 19 | Samostatna ordinace praktickeho lekare pro deti a dorost | Chrudimska 2a | Praha 3 | Czech Republic | 130 00 |
| 20 | Samostatna ordinace praktickeho lekare pro deti a dorost | Kladenská 53 | Praha 6 | Czech Republic | 160 00 |
| 21 | Samostatna ordinace praktickeho lekare pro deti a dorost | Velka Michalska 22 | Znojmo | Czech Republic | 669 00 |
| 22 | Házi Gyermekorvosi szolgálat | Honvéd u.2. | Bordány | Hungary | 6795 |
| 23 | Medszolg 2000 Bt, 6723, Szeged, Dandár u.4 | Ányos u.4. | Budapest | Hungary | 1031 |
| 24 | Erzsébet Kórház Gyermekosztály | Hodmezovasarhely | dr. Imre József u.2. | Hungary | |
| 25 | Baby Box Bt,, 6724, Szeged, Kossuth Lajos sgt.109 | Szeged | Kossuth Lajos sgt.109 | Hungary | |
| 26 | Dr. Bán Mariann és Társa Bt. | Kando Kalman u.1 | Miskolc | Hungary | 3534 |
| 27 | Futurnest Kft | Selyemrét u.1. | Miskolc | Hungary | 3527 |
| 28 | Ped-Med Kft. , 3434 Mályi, Fő u.12. | Fő u.12. | Mályi | Hungary | 3434 |
| 29 | S.K. Sipka és Kovács Eü. Bt. | Csongrádi sgt. 63. | Szeged | Hungary | 6723 |
| 30 | Oszila Kft. 6723, Szeged, Debreceni u.10-14. | Debreceni u.10-14. | Szeged | Hungary | 6723 |
| 31 | Győriné dr. Bari Eszter egyéni vállalkozó | Csongrad | Szentháromság tér 10 | Hungary | |
| 32 | Vas Megyei Markusovszky Kórház, Gyermekosztály | Markusovszky u. 1-3 | Szombathely | Hungary | 9700 |
| 33 | Dipartimento di Neonatologia e Terapia Intensiva Neonatale, "Ospedale dei Bambini", Presidio Ospedaliero dell'Azienda Ospedaliera Spedali Civili di Brescia | P.le Spedali di Brescia,1 | Brescia | Italy | 25125 |
| 34 | Dipartimento di Pediatria dell'Università degli Studi di Firenze | Viale Pieraccini n. 24 | Firenze | Italy | 50139 |
| 35 | Università degli Studi di Messina, Pad. NI - A.O.U. Policlinico G.Martino | Via Consolare Valeria, 1 | Messina | Italy | 98125 |
| 36 | Fondazione IRCCS dell'Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena di Milano | Via Commenda, 9 | Milano | Italy | 20122 |
| 37 | Pediatria dell'Ospedale Sacco di Milano | Via G.B.Grossi 74 | Milano | Italy | 20157 |
| 38 | Dipartimento di Pediatria Azienda Ospedaliera di Padova | Via Giustiniani, 3 | Padova | Italy | 35128 |
Sponsors and Collaborators
- Novartis Vaccines
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Novartis Vaccines
ClinicalTrials.gov Identifier:
NCT00937521
Other Study ID Numbers:
- V72P16
- 2009-010106-11
First Posted:
Jul 13, 2009
Last Update Posted:
Apr 7, 2015
Last Verified:
Mar 1, 2015
Keywords provided by Novartis Vaccines
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | B+OMV (Group I) | B+½ OMV (Group II) | B+1/4 OMV (Group III) | B (Group IV) | ½ (B+OMV) (Group V) | PH2 B+OMV (Group VI) | MenC (Group VII) | Par+B+OMV (Group VIII) |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. | Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. | Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. | Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. | Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. | Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. | Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age. | Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age. |
| Period Title: Overall Study - Prior to Booster Dose | ||||||||
| STARTED | 188 | 190 | 192 | 188 | 191 | 188 | 186 | 184 |
| Premature Withdrawal | 3 | 5 | 6 | 1 | 3 | 1 | 5 | 1 |
| COMPLETED | 185 | 185 | 186 | 187 | 188 | 187 | 181 | 183 |
| NOT COMPLETED | 3 | 5 | 6 | 1 | 3 | 1 | 5 | 1 |
| Period Title: Overall Study - Prior to Booster Dose | ||||||||
| STARTED | 155 | 163 | 169 | 170 | 168 | 165 | 165 | 161 |
| Premature Withdrawal | 3 | 2 | 5 | 3 | 5 | 5 | 5 | 2 |
| COMPLETED | 152 | 161 | 164 | 167 | 163 | 160 | 160 | 159 |
| NOT COMPLETED | 3 | 2 | 5 | 3 | 5 | 5 | 5 | 2 |
Baseline Characteristics
| Arm/Group Title | B+OMV (Group I) | B+½ OMV (Group II) | B+1/4 OMV (Group III) | B (Group IV) | ½ (B+OMV) (Group V) | PH2 B+OMV (Group VI) | MenC (Group VII) | Par+B+OMV (Group VIII) | Total |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. | Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. | Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. | Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. | Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. | Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. | Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age. | Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age. | Total of all reporting groups |
| Overall Participants | 188 | 190 | 192 | 188 | 191 | 188 | 186 | 184 | 1507 |
| Age (Count of Participants) | |||||||||
| <=18 years |
188
100%
|
190
100%
|
192
100%
|
188
100%
|
191
100%
|
188
100%
|
186
100%
|
184
100%
|
1507
100%
|
| Between 18 and 65 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Sex: Female, Male (Count of Participants) | |||||||||
| Female |
88
46.8%
|
91
47.9%
|
82
42.7%
|
96
51.1%
|
79
41.4%
|
93
49.5%
|
98
52.7%
|
72
39.1%
|
699
46.4%
|
| Male |
100
53.2%
|
99
52.1%
|
110
57.3%
|
92
48.9%
|
112
58.6%
|
95
50.5%
|
88
47.3%
|
112
60.9%
|
808
53.6%
|
Outcome Measures
| Title | Percentages of Subjects With Serum Bactericidal Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination |
|---|---|
| Description | To assess the immunogenicity of seven different formulations of 4CMenB (groups I-VI and VIII) given to healthy infants at 2,3 and 4 months of age as measured by percentages of subjects with serum bactericidal activity (SBA) titer≥1:5 against 44/76-SL, 5/99 and NZ98/254 reference strains, at 1 month after the third vaccination.. The analysis was done on the Per Protocol Primary Population at one month after third injection. |
| Time Frame | At baseline (pre-vaccination) and 30 days after the third vaccination. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis as per PP population. |
| Arm/Group Title | B+OMV (Group I) | B+½ OMV (Group II) | B+1/4 OMV (Group III) | B (Group IV) | ½ (B+OMV) (Group V) | PH2 B+OMV (Group VI) | MenC (Group VII) | Par+B+OMV (Group VIII) |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. | Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. | Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. | Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. | Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. | Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. | Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age. | Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age. |
| Measure Participants | 171 | 174 | 171 | 174 | 172 | 173 | 171 | 169 |
| 44/76SLBaseline(N=166,171,168,170,169,168,168,166) |
5
|
2
|
4
|
4
|
4
|
4
|
2
|
3
|
| 44/76-SL > 3rd(N=170,170,166,166,169,167,165,167) |
100
|
99
|
99
|
100
|
99
|
99
|
6
|
100
|
| 5/99-Baseline (N=162,162,161,161,166,166,161,157) |
5
|
3
|
6
|
4
|
8
|
4
|
6
|
4
|
| 5/99 > 3rd (N=165,167,161,166,165,161,159,160) |
99
|
100
|
99
|
100
|
100
|
99
|
3
|
99
|
| NZ98/254Baseline(N=170,174,171,174,171,173,171,169 |
1
|
0
|
1
|
1
|
1
|
1
|
2
|
1
|
| NZ98/254 > 3rd (N=171,172,169,168,172,169,168,168) |
78
|
67
|
56
|
1
|
62
|
81
|
2
|
74
|
| Title | Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) |
|---|---|
| Description | ToTo assess the immune response of seven different formulations of meningococcal multi-component recombinant, adsorbed vaccine (rMenB+OMV NZ or rMenB (no OMV)) in healthy toddlers as measured by SBA geometric mean titers (GMTs) at: One month after third vaccination. One month after booster vaccination (Men B at 12 months of age). |
| Time Frame | At baseline (pre-vaccination), 30 days after the third vaccination, at booster Baseline and at booster vaccination (12 months of age) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per Protocol Primary and Booster populations. |
| Arm/Group Title | B+OMV (Group I) | B+½ OMV (Group II) | B+1/4 OMV (Group III) | B (Group IV) | ½ (B+OMV) (Group V) | PH2 B+OMV (Group VI) | MenC (Group VII) | Par+B+OMV (Group VIII) |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. | Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. | Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. | Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. | Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. | Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. | Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age. | Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age. |
| Measure Participants | 171 | 174 | 171 | 174 | 172 | 173 | 171 | 169 |
| 44/76-SL Base(N=166,171,168,170,169,168,168,166) |
1.25
|
1.12
|
1.2
|
1.19
|
1.31
|
1.2
|
1.16
|
1.18
|
| 44/76-SL > 3(N=170,170,166,166,169,167,165,167) |
101
|
112
|
113
|
62
|
71
|
102
|
1.24
|
102
|
| 44/76-SL - Base Boost(N=69,78,74,78,71,71,74,70) |
4.94
|
5.22
|
5.72
|
5.44
|
3.96
|
3.76
|
1.15
|
4.51
|
| 44/76-SL > Boost(N=65,73,70,75,76,71,75,63) |
120
|
152
|
118
|
53
|
99
|
105
|
12
|
136
|
| 5/99-Baseline-(N=162,162,161,161,166,166,161,157) |
1.18
|
1.09
|
1.12
|
1.13
|
1.3
|
1.16
|
1.21
|
1.07
|
| 5/99 > 3 (N=165,167,161,166,165,161,160) |
396
|
503
|
534
|
389
|
316
|
371
|
1.15
|
455
|
| 5/99 Base Boost(N=71,76,80,72,77,78,70,71) |
69
|
91
|
111
|
74
|
54
|
64
|
1.11
|
106
|
| 5/99 > Boost(N=73,77,79,72,76,74,69,76) |
1950
|
1819
|
2238
|
730
|
983
|
1321
|
41
|
2182
|
| NZ98/254-BaselineN=170,174,171,174,171,173,171,169 |
1.02
|
1.02
|
1.03
|
1.04
|
1.03
|
1.04
|
1.06
|
1.02
|
| 1month after 3rd vaccN=171,172,169,172,169,169,168 |
10
|
7.81
|
5.74
|
1.05
|
6.66
|
11
|
1.05
|
8.48
|
| NZ98/254 Bas Bst N=141,155,155,150,150,153,148,143 |
1.6
|
1.28
|
1.23
|
1.11
|
1.35
|
1.41
|
1.03
|
1.48
|
| 1month after boosterN=138,152,150,149,152,146,140 |
20
|
18
|
11
|
1.67
|
14
|
20
|
2.2
|
20
|
| Title | Geometric Mean Bactericidal Titers,One Month After Primary and Booster Vaccination (Men B at 12 Months of Age) |
|---|---|
| Description | To compare the antibody response of meningococcal multi-component recombinant, adsorbed vaccine (formulation I vs. formulation VIII) and of routine infant vaccine given with or without prophylactic administration of paracetamol medication in healthy toddlers. |
| Time Frame | At Baseline (pre-vaccination), at 30 days after the third vaccination, at booster Baseline, at 30 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| As per PP population. |
| Arm/Group Title | B+OMV (Group I) | Par+B+OMV (Group VIII) |
|---|---|---|
| Arm/Group Description | Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. | Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age. |
| Measure Participants | 171 | 169 |
| 44/76-SL Strain - Baseline (N=166,166) |
1.25
|
1.18
|
| 44/76-SL > 3rd (N=170,167) |
101
|
102
|
| 44/76-SL Baseline booster (N=69,70) |
4.94
|
4.51
|
| 44/76-SL > booster (N=65,63) |
120
|
136
|
| 5/99 Strain - Baseline (N=162,157) |
1.18
|
1.07
|
| 5/99 > 3rd (N=165,160) |
396
|
455
|
| 5/99 Baseline booster (N=71,71) |
69
|
106
|
| 5/99 > booser (N=73,76) |
1950
|
2182
|
| NZ98/254 Strain-Baseline (N=170,169) |
1.02
|
1.02
|
| NZ98/254 > 3rd (N=171,168) |
10
|
8.48
|
| NZ98/254 Baseline booster (N=141,143) |
1.6
|
1.48
|
| NZ98/254 > booster (N= 138, 140) |
20
|
20
|
| Title | Geometric Mean Ratios, One Month After Primary and Booster Vaccination (Men B at 12 Months of Age) |
|---|---|
| Description | To compare the antibody response between meningococcal multi-component recombinant adsorbed vaccine (formulation I) and routine infant vaccine group along with meningococcal multi-component recombinant adsorbed vaccine with prophylactic administration of paracetamol medication as measured by Geometric Mean Ratios (GMRs). |
| Time Frame | After the third and the booster vaccination. |
Outcome Measure Data
| Analysis Population Description |
|---|
| As per PP population. |
| Arm/Group Title | B+OMV (Group I) | Par+B+OMV (Group VIII) |
|---|---|---|
| Arm/Group Description | Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. | Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age. |
| Measure Participants | 162 | 160 |
| 44/76-SL > 3rd (N=157,157) |
80
|
84
|
| 44/76-SL > Booster (N=59,56) |
24
|
28
|
| 5/99 > 3rd (N=152,142) |
345
|
417
|
| 5/99 > Booster (N=68,68) |
27
|
20
|
| NZ98/254 > 3rd (N=162,160) |
9.65
|
8.69
|
| NZ98/254 > Booster (N=129,127) |
12
|
14
|
| Title | Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (Pre-fourth Dose) |
|---|---|
| Description | To assess the persistence of bactericidal antibodies at 12 months of age after primary vaccination - three doses of one of the seven different formulations of rMenB+OMV NZ or rMenB (no OMV) (Group I-VI and VIII) and rMenB+OMV NZ with paracetamol medication. |
| Time Frame | 12 months (pre-fourth vaccination) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was done on the Per Protocol Booster population. |
| Arm/Group Title | B+OMV (Group I) | B+½ OMV (Group II) | B+1/4 OMV (Group III) | B (Group IV) | ½ (B+OMV) (Group V) | PH2 B+OMV (Group VI) | MenC (Group VII) | Par+B+OMV (Group VIII) |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.. | Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. | Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. | Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.. | Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. | Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. | Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age. | Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age. |
| Measure Participants | 141 | 155 | 155 | 150 | 150 | 153 | 148 | 143 |
| 44/76-SL Pre-Boost(N=69,78,74,78,71,71,74,70) |
55
|
58
|
66
|
63
|
45
|
44
|
4
|
47
|
| 5/99 Pre-Boost(N=71,76,80,72,77,78,70,71) |
97
|
100
|
100
|
97
|
97
|
99
|
1
|
100
|
| NZ98/254 Pre-B(N=141,155,155,150,150,153,148,143) |
12
|
6
|
5
|
3
|
7
|
8
|
0
|
11
|
| Title | Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (One Month-post Fourth Dose) |
|---|---|
| Description | To assess if any of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (groups I-VI and VIII) induced sufficient immune response when given to healthy toddlers at 12 months of age, as measured by percentage of subjects with SBA titer ≥ 1:5, at 1 month after the fourth vaccination. |
| Time Frame | 1 month after fourth vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was done on the Per Protocol Booster population. |
| Arm/Group Title | B+OMV (Group I) | B+½ OMV (Group II) | B+1/4 OMV (Group III) | B (Group IV) | ½ (B+OMV) (Group V) | PH2 B+OMV (Group VI) | MenC (Group VII) | Par+B+OMV (Group VIII) |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. | Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. | Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. | Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. | Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. | Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. | Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age. | Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age. |
| Measure Participants | 138 | 152 | 150 | 149 | 152 | 146 | 147 | 140 |
| 44/76-SL > Booster(N=65,73,70,75,76,71,63) |
100
|
100
|
100
|
97
|
100
|
99
|
84
|
100
|
| 5/99 strain (N=73,77,79,72,76,74,76) |
100
|
100
|
100
|
100
|
100
|
100
|
93
|
100
|
| NZ98/254 (N=138,152,150,149,152,146,147,140) |
89
|
89
|
78
|
18
|
83
|
88
|
24
|
90
|
| Title | Geometric Mean Bactericidal Titers, After Primary and Booster Vaccinations (Men B at 12 Months of Age) |
|---|---|
| Description | To assess the induction of immunological memory of three doses of meningococcal multi-component recombinant, adsorbed vaccine by comparing the serum bactericidal antibodies Geometric Mean Bactericidal Titers (GMTs) response in healthy toddlers administered the fourth dose at 12 months of age to the response in meningococcal B vaccine naive toddlers (Group VII) receiving the first dose of meningococcal multi-component recombinant, adsorbed vaccine at 12 months of age. |
| Time Frame | At 13 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was done on the Per Protocol population. |
| Arm/Group Title | B+OMV (Group I) | MenC (Group VII) |
|---|---|---|
| Arm/Group Description | Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. | Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age. |
| Measure Participants | 138 | 147 |
| 44/76-SL > Booster (N=65,75) |
120
|
12
|
| 5/99 > Booster (N=73,69) |
1950
|
41
|
| NZ98/254 > Booster |
20
|
2.2
|
| Title | Percentage of Subjects With hSBA ≥1:5, First Dose of Meningococcal B Vaccine (One Month After Booster) |
|---|---|
| Description | To assess the immune response of first dose of meningococcal multi-component recombinant, adsorbed vaccine given at 12 months of age to toddlers who previously received three doses of MenC-CRM197 vaccine as infants (group VII). |
| Time Frame | 1 month after booster |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was done on the Per Protocol population. |
| Arm/Group Title | MenC (Group VII) |
|---|---|
| Arm/Group Description | Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age. |
| Measure Participants | 147 |
| 44/76-SL > Booster (N=75) |
84
|
| 5/99 > Booster (N=69) |
93
|
| NZ98/254 > Booster |
24
|
| Title | Safety and Reactogenicity of Study Vaccines Within 7 Days After Second and Third Vaccination |
|---|---|
| Description | To assess if any of six different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (Group II to VI, Group VIII) reduced the incidence of fever ≥ 38.5ºC (rectal) occurring within 3 days (day 1-3) following second and third vaccination and 7 days (day 1-7) following each vaccination as compared to rMenB+OMV NZ (Group I). |
| Time Frame | Day 1 through day 7 after second and third vaccination. |
Outcome Measure Data
| Analysis Population Description |
|---|
| As per safety dataset. |
| Arm/Group Title | B+OMV (Group I) | B+½ OMV (Group II) | B+1/4 OMV (Group III) | B (Group IV) | ½ (B+OMV) (Group V) | PH2 B+OMV (Group VI) | MenC (Group VII) | Par+B+OMV (Group VIII) |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.. | Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. | Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. | Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. | Subjects in this group received one dose of meningococcal multi-component recombinant, adsorbed vaccine (formulation V)and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. | Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.. | Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age. | Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age. |
| Measure Participants | 182 | 180 | 186 | 184 | 182 | 180 | 177 | 179 |
| Second Vaccination (day1-3) |
90
|
82
|
76
|
35
|
74
|
89
|
30
|
33
|
| 3rd vac d 1-3(N=181,179,185,183,181,180,177,179) |
55
|
50
|
36
|
15
|
40
|
53
|
12
|
20
|
| First Vaccination (day1-7) |
94
|
91
|
74
|
24
|
60
|
76
|
22
|
46
|
| Second Vaccination (day 1-7) |
90
|
82
|
77
|
36
|
74
|
90
|
30
|
35
|
| 3rd vac d 1-7(N=181,179,185,183,181,180,177,179) |
55
|
53
|
38
|
16
|
42
|
54
|
14
|
20
|
| Booster d 1-7(N=155,162,169,168,168,165,164,159) |
81
|
86
|
64
|
43
|
78
|
68
|
84
|
58
|
| Title | Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination |
|---|---|
| Description | To assess the safety and tolerability of each of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (group I to VI, group VIII) in terms of number of subjects reporting solicited local reactions within 7 days (day 1-7) after each vaccination. |
| Time Frame | Day 1 through day 7 after each vaccination. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the safety population. |
| Arm/Group Title | B+OMV (Group I) | B+½ OMV (Group II) | B+1/4 OMV (Group III) | B (Group IV) | ½ (B+OMV) (Group V) | PH2 B+OMV (Group VI) | MenC (Group VII) | Par+B+OMV (Group VIII) |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. | Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. | Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. | Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. | Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. | Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. | Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age. | Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age. |
| Measure Participants | 182 | 180 | 186 | 184 | 182 | 180 | 177 | 179 |
| Any Local (First Vacc) |
163
|
155
|
153
|
123
|
141
|
157
|
127
|
137
|
| Injection Site Tenderness (First Vacc) |
114
|
116
|
111
|
54
|
97
|
121
|
48
|
79
|
| Injection Site Erythema (First Vacc) |
108
|
99
|
94
|
53
|
77
|
106
|
45
|
73
|
| Injection Site Induration (First Vacc) |
101
|
98
|
85
|
48
|
86
|
84
|
25
|
82
|
| Injection Site Swelling (First Vacc) |
58
|
49
|
55
|
24
|
48
|
60
|
15
|
41
|
| Any Local (Second Vacc) |
156
|
156
|
155
|
126
|
132
|
156
|
118
|
140
|
| Injection Site Tenderness (Second Vacc) |
121
|
116
|
97
|
48
|
88
|
116
|
47
|
85
|
| Injection Site Erythema (Second Vacc) |
104
|
114
|
114
|
71
|
90
|
104
|
44
|
94
|
| Injection Site Induration (Second Vacc) |
103
|
105
|
97
|
63
|
83
|
94
|
38
|
79
|
| Injection Site Swelling (Second Vacc) |
64
|
61
|
54
|
34
|
50
|
58
|
21
|
52
|
| Any Local (3rd N=181,179,185,183,181,180,177,179) |
151
|
147
|
141
|
122
|
130
|
152
|
113
|
128
|
| Injection Site Tenderness (Third Vacc) |
102
|
98
|
78
|
47
|
77
|
111
|
42
|
66
|
| Injection Site Erythema (Third Vacc) |
110
|
106
|
112
|
72
|
94
|
101
|
63
|
91
|
| Injection Site Induration (Third Vacc) |
97
|
92
|
92
|
62
|
79
|
89
|
55
|
80
|
| Injection Site Swelling (Third Vacc) |
56
|
56
|
46
|
35
|
45
|
58
|
29
|
47
|
| Any Local BoostN=155,162,169,168,168,165,162,159 |
131
|
132
|
149
|
113
|
127
|
130
|
133
|
121
|
| Injection Site Tenderness (Booster Vacc) |
116
|
107
|
120
|
77
|
106
|
112
|
108
|
92
|
| Injection Site Erythema (Booster Vacc) |
90
|
101
|
116
|
67
|
80
|
85
|
93
|
81
|
| Injection Site Induration (Booster Vacc) |
73
|
83
|
95
|
56
|
66
|
73
|
62
|
60
|
| Injection Site Swelling (Booster Vacc) |
55
|
59
|
69
|
31
|
47
|
52
|
39
|
47
|
| Title | Number of Subjects With Fever ≥ 38.5 °C (Rectal Temperature) Within 3 Days (Day 1-3) After First Vaccination |
|---|---|
| Description | To assess if any of six different formulations of vaccine groups (Group II to Group VI, Group VIII) reduced the incidence of fever >=38.5C (rectal) occurring within three days (day 1-day3) following first vaccination. The analysis was done on the Safety Population. |
| Time Frame | Day 1 to day 3 after first vaccination. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was done on the Safety Population. |
| Arm/Group Title | B+OMV (Group I) | B+½ OMV (Group II) | B+1/4 OMV (Group III) | B (Group IV) | ½ (B+OMV) (Group V) | PH2 B+OMV (Group VI) | MenC (Group VII) | Par+B+OMV (Group VIII) |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. | Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. | Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. | Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. | Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. | Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. | Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age. | Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age. |
| Measure Participants | 182 | 180 | 186 | 184 | 182 | 180 | 177 | 179 |
| Number [Subjects] |
94
|
91
|
74
|
24
|
60
|
76
|
21
|
46
|
| Title | Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination |
|---|---|
| Description | To assess the safety and tolerability of each of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (group I to VI, group VIII) in terms of number of subjects reporting solicited systemic reactions within 7 days (day 1-7) after each vaccination. |
| Time Frame | Day 1 through day 7 after each vaccination. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the safety population. |
| Arm/Group Title | B+OMV (Group I) | B+½ OMV (Group II) | B+1/4 OMV (Group III) | B (Group IV) | ½ (B+OMV) (Group V) | PH2 B+OMV (Group VI) | MenC (Group VII) | Par+B+OMV (Group VIII) |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. | Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. | Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. | Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. | Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. | Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. | Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age. | Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age. |
| Measure Participants | 182 | 180 | 186 | 184 | 182 | 180 | 177 | 179 |
| Any Systemic (First Vacc) |
167
|
173
|
175
|
152
|
162
|
171
|
136
|
150
|
| Change Eat. Habits (First Vacc) |
76
|
87
|
84
|
52
|
84
|
90
|
41
|
66
|
| Sleepiness (First Vacc) |
120
|
131
|
119
|
96
|
117
|
119
|
92
|
116
|
| Vomiting (First Vacc) |
24
|
18
|
25
|
15
|
22
|
26
|
17
|
22
|
| Diarrhea (First Vacc) |
57
|
55
|
54
|
31
|
41
|
49
|
45
|
41
|
| Irritability (First Vacc) |
128
|
124
|
128
|
99
|
131
|
131
|
79
|
97
|
| Unus Crying (First Vacc) |
95
|
101
|
105
|
61
|
96
|
108
|
63
|
74
|
| Rash (First Vacc) |
6
|
5
|
5
|
7
|
10
|
10
|
4
|
5
|
| Fever ( ≥ 38.5°C ) (First Vacc) |
94
|
91
|
74
|
24
|
60
|
76
|
22
|
46
|
| Antipyr. Med. Used (First Vacc) |
102
|
94
|
92
|
37
|
74
|
95
|
32
|
166
|
| Any Systemic (Second Vacc) |
168
|
158
|
166
|
144
|
156
|
158
|
126
|
147
|
| Change Eat. Habits (Second Vacc) |
62
|
55
|
58
|
53
|
60
|
80
|
33
|
54
|
| Sleepiness (Second Vacc) |
105
|
100
|
102
|
85
|
92
|
109
|
75
|
84
|
| Vomiting (Second Vacc) |
18
|
18
|
14
|
15
|
17
|
20
|
14
|
20
|
| Diarrhea (Second Vacc) |
43
|
41
|
47
|
40
|
39
|
47
|
39
|
40
|
| Irritability (Second Vacc) |
130
|
121
|
124
|
94
|
117
|
126
|
82
|
99
|
| Unus Crying (Second Vacc) |
90
|
90
|
84
|
70
|
83
|
99
|
45
|
71
|
| Rash (Second Vacc) |
4
|
9
|
4
|
5
|
7
|
4
|
5
|
5
|
| Fever ( ≥ 38.5°C ) (Second Vacc) |
90
|
82
|
77
|
36
|
74
|
90
|
30
|
35
|
| Antipyr. Med. Used (Second Vacc) |
100
|
94
|
83
|
40
|
79
|
105
|
39
|
163
|
| Any Syst (3rdN=181,179,185,182,181,180,177,179) |
146
|
131
|
132
|
122
|
141
|
151
|
106
|
127
|
| Change Eat. Habits (Third Vacc) |
49
|
50
|
42
|
37
|
45
|
60
|
22
|
48
|
| Sleepiness (Third Vacc) |
75
|
67
|
82
|
64
|
77
|
79
|
52
|
75
|
| Vomiting (Third Vacc) |
8
|
18
|
15
|
12
|
12
|
13
|
11
|
20
|
| Diarrhea (Third Vacc) |
33
|
29
|
39
|
31
|
34
|
40
|
19
|
32
|
| Irritability (Third Vacc) |
115
|
97
|
93
|
74
|
104
|
115
|
76
|
84
|
| Unus Crying (Third Vacc) |
76
|
82
|
62
|
47
|
69
|
100
|
38
|
47
|
| Rash (Third Vacc) |
1
|
6
|
4
|
2
|
8
|
10
|
6
|
6
|
| Fever ( ≥ 38.5°C ) (Third Vacc) |
55
|
53
|
38
|
16
|
42
|
54
|
14
|
20
|
| Antipyr. Med. Used (Third Vacc) |
66
|
60
|
51
|
26
|
49
|
63
|
20
|
153
|
| Any Syst(BoosterN=155,162,169,169,168,165,164,159) |
143
|
144
|
139
|
118
|
141
|
142
|
142
|
137
|
| Change Eat. Habits (Booster Vacc) |
74
|
77
|
79
|
52
|
70
|
80
|
59
|
66
|
| Sleepiness (Booster Vacc) |
76
|
90
|
90
|
63
|
86
|
88
|
85
|
80
|
| Vomiting (Booster Vacc) |
6
|
11
|
7
|
7
|
10
|
9
|
9
|
20
|
| Diarrhea (Booster Vacc) |
30
|
34
|
36
|
43
|
32
|
30
|
26
|
30
|
| Irritability (Booster Vacc) |
116
|
111
|
112
|
86
|
116
|
115
|
117
|
96
|
| Unus Crying (Booster Vacc) |
74
|
64
|
69
|
46
|
71
|
82
|
73
|
50
|
| Rash (Booster Vacc) |
5
|
5
|
8
|
2
|
8
|
4
|
6
|
5
|
| Fever ( ≥ 38.5°C ) (Booster Vacc) |
81
|
86
|
64
|
43
|
78
|
68
|
84
|
58
|
| Antipyr. Med. Used (Booster Vacc) |
84
|
82
|
83
|
42
|
75
|
80
|
92
|
128
|
| Title | Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination |
|---|---|
| Description | To assess the safety and tolerability of each of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (group I to VI, group VIII) in terms of number of subjects reporting unsolicited Adverse Events (AEs), serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal (throughout the study period) within 7 days (day 1-7) after each vaccination. |
| Time Frame | Day 1 through day 7 after each vaccination. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the safety population. |
| Arm/Group Title | B+OMV (Group I) | B+½ OMV (Group II) | B+1/4 OMV (Group III) | B (Group IV) | ½ (B+OMV) (Group V) | PH2 B+OMV (Group VI) | MenC (Group VII) | Par+B+OMV (Group VIII) |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. | Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. | Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. | Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. | Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. | Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. | Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age. | Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age. |
| Measure Participants | 184 | 184 | 189 | 187 | 187 | 185 | 184 | 183 |
| Any AE (Day 1 to 7) (First Vacc) |
55
|
52
|
51
|
33
|
35
|
39
|
27
|
42
|
| At least Possibly related AE (First Vacc) |
48
|
48
|
43
|
30
|
27
|
34
|
22
|
36
|
| Any SAE (First Vacc) |
0
|
1
|
0
|
0
|
0
|
1
|
0
|
1
|
| Any AE D1-7 2nd N=182,181,186,184,183,180,178,180 |
55
|
53
|
50
|
41
|
36
|
47
|
28
|
45
|
| At least Possibly related AE (Second Vaccination) |
49
|
45
|
45
|
36
|
33
|
41
|
26
|
39
|
| Any SAE (Second Vacc) |
1
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
| Any AE D1-7 3rd N=182,181,186,184,182,180,177,179 |
40
|
59
|
49
|
35
|
31
|
45
|
35
|
39
|
| At least Possibly related AE (Third Vacc) |
34
|
52
|
45
|
29
|
23
|
37
|
29
|
36
|
| Any SAE (Third Vacc) |
2
|
0
|
2
|
0
|
1
|
0
|
0
|
0
|
| Any AE D 1-7Boos N=155,163,169,169,168,165,165,161 |
35
|
46
|
56
|
35
|
29
|
30
|
37
|
30
|
| At least Possibly related AE (Booster Vacc) |
28
|
41
|
48
|
23
|
23
|
26
|
30
|
25
|
| Any SAE (Booster Vacc) |
0
|
1
|
2
|
0
|
3
|
0
|
0
|
0
|
| Title | Number of Subjects With Severe Adverse Events and Adverse Events Necessitating a Medical Office or Emergency Room (ER) Visit and/or Resulting in Premature Withdrawal of the Subject From the Study, Throughout the Study Period. |
|---|---|
| Description | To assess the safety and tolerability of each of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (group I to VI, group VIII) in terms of number of subjects reporting Severe Adverse Events (SAEs) and Adverse Events (AEs) necessitating a medical office or Emergency Room (ER) visit and/or resulting in premature withdrawal of the subject from the study, throughout the study period. |
| Time Frame | Overall study period. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the safety population. |
| Arm/Group Title | B+OMV (Group I) | B+½ OMV (Group II) | B+1/4 OMV (Group III) | B (Group IV) | ½ (B+OMV) (Group V) | PH2 B+OMV (Group VI) | MenC (Group VII) | Par+B+OMV (Group VIII) |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. | Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. | Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. | Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. | Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. | Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. | Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age. | Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age. |
| Measure Participants | 184 | 184 | 189 | 187 | 187 | 185 | 184 | 183 |
| AE Leading to Premature Withdrawal-Primary Vacc |
0
|
2
|
2
|
0
|
0
|
1
|
2
|
1
|
| Treatment Emergent SAEs - Primary Vacc |
16
|
20
|
12
|
20
|
13
|
16
|
11
|
15
|
| Tr E SAE Boost (N=155,163,169,169,168,165,165,161) |
14
|
7
|
12
|
5
|
15
|
9
|
9
|
16
|
| Title | Number of Subjects With Local and Systemic Reactions Within 7 Days (Day 1-7) After Second rMenB+OMV NZ Vaccination in MenC Group |
|---|---|
| Description | To assess the safety and tolerability of two doses of rMenB+OMV NZ vaccine (Group VII) given at 12 and 13 months of age to toddlers who previously received three doses of Menjugate as infants. |
| Time Frame | Day 1 through day 7 at 13 months age. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the safety population. |
| Arm/Group Title | MenC (Group VII) |
|---|---|
| Arm/Group Description | Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age. |
| Measure Participants | 156 |
| Injection Site Tenderness |
92
|
| Injection Site Erythema |
84
|
| Injection Site Induration |
59
|
| Injection Site Swelling |
35
|
| Change Eat. Habits (N=155) |
43
|
| Sleepiness |
57
|
| Vomiting |
8
|
| Diarrhea |
18
|
| Irritability |
75
|
| Unus Crying |
37
|
| Rash |
4
|
| Fever ( ≥ 38.5°C ) (N=158) |
35
|
| Antipyr. Med. Used (N=157) |
47
|
Adverse Events
| Time Frame | All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period. | |||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||||||||||||||||||||||||
| Arm/Group Title | B+OMV (Group I) | B+½ OMV (Group II) | B+1/4 OMV (Group III) | B (Group IV) | ½ (B+OMV) (Group V) | PH2 B+OMV (Group VI) | MenC (Group VII) | Par+B+OMV (Group VIII) | B+OMV (Group I) Booster Phase | B+½ OMV (Group II) Booster Phase | B+1/4 OMV (Group III) Booster Phase | B (Group IV) Booster Phase | ½ (B+OMV) (Group V) Booster Phase | PH2 B+OMV (Group VI) Booster Phase | MenC (Group VII) Booster Phase | Par+B+OMV (Group VIII) Booster Phase | ||||||||||||||||
| Arm/Group Description | Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. Group defined to be applicable Prior to Booster Phase for AEs reporting. | Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. Group defined to be applicable Prior to Booster Phase for AEs reporting. | Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. Group defined to be applicable Prior to Booster Phase for AEs reporting. | Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. Group defined to be applicable Prior to Booster Phase for AEs reporting.. | Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. Group defined to be applicable Prior to Booster Phase for AEs reporting. | SubjSubjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. Group defined to be applicable Prior to Booster Phase for AEs reporting. | Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age and one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age. One dose of MenC at 13 months of age. Group defined to be applicable Prior to Booster Phase for AEs reporting. | Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. Group defined to be applicable Prior to Booster Phase for AEs reporting. | Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. | Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine(formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. Group defined to include Booster Phase. | Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. Group defined to include Booster Phase. | Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. Group defined to include Booster Phase. | Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. Group defined to include Booster Phase. | Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. Group defined to include Booster Phase. | Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age and one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age. One dose of MenC at 13 months of age. Group defined to include Booster Phase. | Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. Group defined to include Booster Phase. | ||||||||||||||||
All Cause Mortality |
||||||||||||||||||||||||||||||||
| B+OMV (Group I) | B+½ OMV (Group II) | B+1/4 OMV (Group III) | B (Group IV) | ½ (B+OMV) (Group V) | PH2 B+OMV (Group VI) | MenC (Group VII) | Par+B+OMV (Group VIII) | B+OMV (Group I) Booster Phase | B+½ OMV (Group II) Booster Phase | B+1/4 OMV (Group III) Booster Phase | B (Group IV) Booster Phase | ½ (B+OMV) (Group V) Booster Phase | PH2 B+OMV (Group VI) Booster Phase | MenC (Group VII) Booster Phase | Par+B+OMV (Group VIII) Booster Phase | |||||||||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||||||||||||||
Serious Adverse Events |
||||||||||||||||||||||||||||||||
| B+OMV (Group I) | B+½ OMV (Group II) | B+1/4 OMV (Group III) | B (Group IV) | ½ (B+OMV) (Group V) | PH2 B+OMV (Group VI) | MenC (Group VII) | Par+B+OMV (Group VIII) | B+OMV (Group I) Booster Phase | B+½ OMV (Group II) Booster Phase | B+1/4 OMV (Group III) Booster Phase | B (Group IV) Booster Phase | ½ (B+OMV) (Group V) Booster Phase | PH2 B+OMV (Group VI) Booster Phase | MenC (Group VII) Booster Phase | Par+B+OMV (Group VIII) Booster Phase | |||||||||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 16/184 (8.7%) | 20/184 (10.9%) | 12/189 (6.3%) | 20/187 (10.7%) | 13/187 (7%) | 16/185 (8.6%) | 11/184 (6%) | 15/183 (8.2%) | 14/155 (9%) | 7/163 (4.3%) | 12/169 (7.1%) | 5/169 (3%) | 15/168 (8.9%) | 9/165 (5.5%) | 9/165 (5.5%) | 14/161 (8.7%) | ||||||||||||||||
| Blood and lymphatic system disorders | ||||||||||||||||||||||||||||||||
| Neutropenia | 0/184 (0%) | 0/184 (0%) | 0/189 (0%) | 1/187 (0.5%) | 0/187 (0%) | 0/185 (0%) | 0/184 (0%) | 0/183 (0%) | 0/155 (0%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 0/168 (0%) | 0/165 (0%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| Anaemia | 0/184 (0%) | 0/184 (0%) | 0/189 (0%) | 0/187 (0%) | 0/187 (0%) | 0/185 (0%) | 0/184 (0%) | 0/183 (0%) | 0/155 (0%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 0/168 (0%) | 1/165 (0.6%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| Lymphadenitis | 0/184 (0%) | 0/184 (0%) | 0/189 (0%) | 0/187 (0%) | 0/187 (0%) | 0/185 (0%) | 0/184 (0%) | 0/183 (0%) | 0/155 (0%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 1/168 (0.6%) | 0/165 (0%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| Cardiac disorders | ||||||||||||||||||||||||||||||||
| Pulmonary valve stenosis | 0/184 (0%) | 0/184 (0%) | 0/189 (0%) | 0/187 (0%) | 0/187 (0%) | 1/185 (0.5%) | 0/184 (0%) | 0/183 (0%) | 0/155 (0%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 0/168 (0%) | 0/165 (0%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| Congenital, familial and genetic disorders | ||||||||||||||||||||||||||||||||
| Congenital megacolon | 0/184 (0%) | 0/184 (0%) | 0/189 (0%) | 1/187 (0.5%) | 0/187 (0%) | 0/185 (0%) | 0/184 (0%) | 0/183 (0%) | 0/155 (0%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 0/168 (0%) | 0/165 (0%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| Cryptorchism | 0/184 (0%) | 0/184 (0%) | 0/189 (0%) | 0/187 (0%) | 0/187 (0%) | 0/185 (0%) | 0/184 (0%) | 0/183 (0%) | 0/155 (0%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 1/168 (0.6%) | 0/165 (0%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| Phimosis | 0/184 (0%) | 0/184 (0%) | 0/189 (0%) | 0/187 (0%) | 0/187 (0%) | 0/185 (0%) | 0/184 (0%) | 0/183 (0%) | 0/155 (0%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 0/168 (0%) | 0/165 (0%) | 0/165 (0%) | 1/161 (0.6%) | ||||||||||||||||
| Gastrointestinal disorders | ||||||||||||||||||||||||||||||||
| Aphthous stomatitis | 0/184 (0%) | 1/184 (0.5%) | 0/189 (0%) | 0/187 (0%) | 0/187 (0%) | 0/185 (0%) | 0/184 (0%) | 0/183 (0%) | 0/155 (0%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 0/168 (0%) | 0/165 (0%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| Enteritis | 0/184 (0%) | 0/184 (0%) | 1/189 (0.5%) | 0/187 (0%) | 0/187 (0%) | 0/185 (0%) | 0/184 (0%) | 0/183 (0%) | 0/155 (0%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 0/168 (0%) | 0/165 (0%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| Enterocolitis haemorrhagic | 0/184 (0%) | 0/184 (0%) | 0/189 (0%) | 0/187 (0%) | 0/187 (0%) | 0/185 (0%) | 0/184 (0%) | 0/183 (0%) | 0/155 (0%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 0/168 (0%) | 0/165 (0%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| Gastritis | 0/184 (0%) | 0/184 (0%) | 0/189 (0%) | 0/187 (0%) | 0/187 (0%) | 1/185 (0.5%) | 0/184 (0%) | 0/183 (0%) | 0/155 (0%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 0/168 (0%) | 0/165 (0%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| Gastrooesophageal reflux disease | 0/184 (0%) | 0/184 (0%) | 1/189 (0.5%) | 0/187 (0%) | 0/187 (0%) | 1/185 (0.5%) | 0/184 (0%) | 1/183 (0.5%) | 0/155 (0%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 0/168 (0%) | 0/165 (0%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| Inguinal hernia | 1/184 (0.5%) | 0/184 (0%) | 0/189 (0%) | 0/187 (0%) | 0/187 (0%) | 0/185 (0%) | 0/184 (0%) | 0/183 (0%) | 1/155 (0.6%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 0/168 (0%) | 1/165 (0.6%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| Vomiting | 0/184 (0%) | 1/184 (0.5%) | 1/189 (0.5%) | 0/187 (0%) | 1/187 (0.5%) | 1/185 (0.5%) | 0/184 (0%) | 0/183 (0%) | 0/155 (0%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 0/168 (0%) | 0/165 (0%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| Diarrhoea | 0/184 (0%) | 0/184 (0%) | 0/189 (0%) | 0/187 (0%) | 0/187 (0%) | 0/185 (0%) | 0/184 (0%) | 0/183 (0%) | 0/155 (0%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 1/168 (0.6%) | 0/165 (0%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| Intussusception | 0/184 (0%) | 0/184 (0%) | 0/189 (0%) | 0/187 (0%) | 0/187 (0%) | 0/185 (0%) | 0/184 (0%) | 0/183 (0%) | 0/155 (0%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 1/168 (0.6%) | 0/165 (0%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| General disorders | ||||||||||||||||||||||||||||||||
| Pyrexia | 1/184 (0.5%) | 0/184 (0%) | 0/189 (0%) | 1/187 (0.5%) | 0/187 (0%) | 1/185 (0.5%) | 0/184 (0%) | 0/183 (0%) | 0/155 (0%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 0/168 (0%) | 0/165 (0%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| Injection site erythema | 0/184 (0%) | 0/184 (0%) | 0/189 (0%) | 0/187 (0%) | 0/187 (0%) | 0/185 (0%) | 0/184 (0%) | 0/183 (0%) | 0/155 (0%) | 0/163 (0%) | 1/169 (0.6%) | 0/169 (0%) | 0/168 (0%) | 0/165 (0%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| Immune system disorders | ||||||||||||||||||||||||||||||||
| Milk allergy | 0/184 (0%) | 0/184 (0%) | 0/189 (0%) | 0/187 (0%) | 0/187 (0%) | 0/185 (0%) | 0/184 (0%) | 0/183 (0%) | 1/155 (0.6%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 0/168 (0%) | 0/165 (0%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| Infections and infestations | ||||||||||||||||||||||||||||||||
| Acarodermatitis | 0/184 (0%) | 0/184 (0%) | 0/189 (0%) | 0/187 (0%) | 0/187 (0%) | 1/185 (0.5%) | 0/184 (0%) | 0/183 (0%) | 0/155 (0%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 0/168 (0%) | 0/165 (0%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| Bacterial pyelonephritis | 0/184 (0%) | 0/184 (0%) | 0/189 (0%) | 1/187 (0.5%) | 0/187 (0%) | 0/185 (0%) | 0/184 (0%) | 0/183 (0%) | 0/155 (0%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 0/168 (0%) | 0/165 (0%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| Bronchiolitis | 1/184 (0.5%) | 0/184 (0%) | 0/189 (0%) | 0/187 (0%) | 1/187 (0.5%) | 1/185 (0.5%) | 0/184 (0%) | 0/183 (0%) | 1/155 (0.6%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 1/168 (0.6%) | 0/165 (0%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| Bronchitis | 3/184 (1.6%) | 2/184 (1.1%) | 4/189 (2.1%) | 4/187 (2.1%) | 1/187 (0.5%) | 2/185 (1.1%) | 2/184 (1.1%) | 1/183 (0.5%) | 1/155 (0.6%) | 1/163 (0.6%) | 2/169 (1.2%) | 0/169 (0%) | 4/168 (2.4%) | 1/165 (0.6%) | 3/165 (1.8%) | 2/161 (1.2%) | ||||||||||||||||
| Bronchopneumonia | 1/184 (0.5%) | 0/184 (0%) | 0/189 (0%) | 1/187 (0.5%) | 0/187 (0%) | 0/185 (0%) | 1/184 (0.5%) | 2/183 (1.1%) | 1/155 (0.6%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 1/168 (0.6%) | 0/165 (0%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| Corona virus infection | 0/184 (0%) | 0/184 (0%) | 0/189 (0%) | 0/187 (0%) | 0/187 (0%) | 0/185 (0%) | 0/184 (0%) | 1/183 (0.5%) | 0/155 (0%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 0/168 (0%) | 0/165 (0%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| Cytomegalovirus infection | 0/184 (0%) | 1/184 (0.5%) | 0/189 (0%) | 0/187 (0%) | 0/187 (0%) | 0/185 (0%) | 0/184 (0%) | 0/183 (0%) | 0/155 (0%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 0/168 (0%) | 0/165 (0%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| Exanthema subitum | 0/184 (0%) | 0/184 (0%) | 2/189 (1.1%) | 0/187 (0%) | 1/187 (0.5%) | 1/185 (0.5%) | 0/184 (0%) | 0/183 (0%) | 0/155 (0%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 0/168 (0%) | 0/165 (0%) | 0/165 (0%) | 1/161 (0.6%) | ||||||||||||||||
| Gastroenteritis | 1/184 (0.5%) | 2/184 (1.1%) | 1/189 (0.5%) | 3/187 (1.6%) | 1/187 (0.5%) | 3/185 (1.6%) | 1/184 (0.5%) | 1/183 (0.5%) | 2/155 (1.3%) | 2/163 (1.2%) | 1/169 (0.6%) | 1/169 (0.6%) | 1/168 (0.6%) | 5/165 (3%) | 0/165 (0%) | 3/161 (1.9%) | ||||||||||||||||
| Gastroenteritis rotavirus | 0/184 (0%) | 0/184 (0%) | 0/189 (0%) | 1/187 (0.5%) | 1/187 (0.5%) | 1/185 (0.5%) | 0/184 (0%) | 1/183 (0.5%) | 0/155 (0%) | 1/163 (0.6%) | 2/169 (1.2%) | 0/169 (0%) | 1/168 (0.6%) | 0/165 (0%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| Gastroenteritis viral | 0/184 (0%) | 0/184 (0%) | 0/189 (0%) | 1/187 (0.5%) | 1/187 (0.5%) | 0/185 (0%) | 0/184 (0%) | 0/183 (0%) | 0/155 (0%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 0/168 (0%) | 0/165 (0%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| Infection | 0/184 (0%) | 1/184 (0.5%) | 0/189 (0%) | 0/187 (0%) | 0/187 (0%) | 0/185 (0%) | 0/184 (0%) | 0/183 (0%) | 0/155 (0%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 0/168 (0%) | 0/165 (0%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| Laryngitis | 0/184 (0%) | 0/184 (0%) | 1/189 (0.5%) | 1/187 (0.5%) | 0/187 (0%) | 3/185 (1.6%) | 0/184 (0%) | 0/183 (0%) | 1/155 (0.6%) | 0/163 (0%) | 1/169 (0.6%) | 3/169 (1.8%) | 2/168 (1.2%) | 0/165 (0%) | 2/165 (1.2%) | 1/161 (0.6%) | ||||||||||||||||
| Nasopharyngitis | 0/184 (0%) | 0/184 (0%) | 0/189 (0%) | 0/187 (0%) | 0/187 (0%) | 0/185 (0%) | 0/184 (0%) | 1/183 (0.5%) | 0/155 (0%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 0/168 (0%) | 1/165 (0.6%) | 0/165 (0%) | 1/161 (0.6%) | ||||||||||||||||
| Oral candidiasis | 0/184 (0%) | 1/184 (0.5%) | 0/189 (0%) | 0/187 (0%) | 0/187 (0%) | 0/185 (0%) | 1/184 (0.5%) | 0/183 (0%) | 0/155 (0%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 0/168 (0%) | 0/165 (0%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| Oral herpes | 0/184 (0%) | 0/184 (0%) | 0/189 (0%) | 0/187 (0%) | 0/187 (0%) | 0/185 (0%) | 1/184 (0.5%) | 0/183 (0%) | 1/155 (0.6%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 0/168 (0%) | 0/165 (0%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| Otitis media acute | 0/184 (0%) | 3/184 (1.6%) | 0/189 (0%) | 0/187 (0%) | 0/187 (0%) | 0/185 (0%) | 1/184 (0.5%) | 0/183 (0%) | 0/155 (0%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 0/168 (0%) | 0/165 (0%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| Pharyngitis | 0/184 (0%) | 0/184 (0%) | 0/189 (0%) | 0/187 (0%) | 0/187 (0%) | 1/185 (0.5%) | 0/184 (0%) | 0/183 (0%) | 0/155 (0%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 0/168 (0%) | 0/165 (0%) | 0/165 (0%) | 1/161 (0.6%) | ||||||||||||||||
| Pneumonia | 0/184 (0%) | 1/184 (0.5%) | 0/189 (0%) | 0/187 (0%) | 0/187 (0%) | 1/185 (0.5%) | 1/184 (0.5%) | 1/183 (0.5%) | 0/155 (0%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 0/168 (0%) | 0/165 (0%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| Pneumonia respiratory syncytial viral | 0/184 (0%) | 0/184 (0%) | 0/189 (0%) | 0/187 (0%) | 1/187 (0.5%) | 0/185 (0%) | 0/184 (0%) | 0/183 (0%) | 0/155 (0%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 0/168 (0%) | 0/165 (0%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| Pneumonia viral | 1/184 (0.5%) | 0/184 (0%) | 0/189 (0%) | 0/187 (0%) | 0/187 (0%) | 0/185 (0%) | 0/184 (0%) | 0/183 (0%) | 0/155 (0%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 0/168 (0%) | 0/165 (0%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| Pyelonephritis | 0/184 (0%) | 1/184 (0.5%) | 1/189 (0.5%) | 1/187 (0.5%) | 0/187 (0%) | 0/185 (0%) | 2/184 (1.1%) | 1/183 (0.5%) | 0/155 (0%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 0/168 (0%) | 0/165 (0%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| Pyelonephritis acute | 0/184 (0%) | 0/184 (0%) | 0/189 (0%) | 0/187 (0%) | 2/187 (1.1%) | 0/185 (0%) | 0/184 (0%) | 0/183 (0%) | 0/155 (0%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 0/168 (0%) | 0/165 (0%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| Respiratory syncytial virus infection | 0/184 (0%) | 0/184 (0%) | 1/189 (0.5%) | 0/187 (0%) | 0/187 (0%) | 0/185 (0%) | 0/184 (0%) | 2/183 (1.1%) | 0/155 (0%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 0/168 (0%) | 0/165 (0%) | 1/165 (0.6%) | 0/161 (0%) | ||||||||||||||||
| Rhinitis | 1/184 (0.5%) | 0/184 (0%) | 0/189 (0%) | 0/187 (0%) | 0/187 (0%) | 0/185 (0%) | 0/184 (0%) | 0/183 (0%) | 0/155 (0%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 0/168 (0%) | 0/165 (0%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| Rhinovirus infection | 0/184 (0%) | 0/184 (0%) | 0/189 (0%) | 0/187 (0%) | 0/187 (0%) | 0/185 (0%) | 0/184 (0%) | 1/183 (0.5%) | 0/155 (0%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 0/168 (0%) | 0/165 (0%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| Sepsis | 0/184 (0%) | 0/184 (0%) | 1/189 (0.5%) | 0/187 (0%) | 0/187 (0%) | 0/185 (0%) | 0/184 (0%) | 0/183 (0%) | 0/155 (0%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 0/168 (0%) | 0/165 (0%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| Upper respiratory tract infection | 0/184 (0%) | 1/184 (0.5%) | 0/189 (0%) | 0/187 (0%) | 0/187 (0%) | 0/185 (0%) | 1/184 (0.5%) | 0/183 (0%) | 0/155 (0%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 0/168 (0%) | 0/165 (0%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| Tonsillitis | 0/184 (0%) | 0/184 (0%) | 0/189 (0%) | 0/187 (0%) | 1/187 (0.5%) | 0/185 (0%) | 0/184 (0%) | 0/183 (0%) | 0/155 (0%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 0/168 (0%) | 0/165 (0%) | 0/165 (0%) | 1/161 (0.6%) | ||||||||||||||||
| Urinary tract infection | 0/184 (0%) | 0/184 (0%) | 0/189 (0%) | 1/187 (0.5%) | 1/187 (0.5%) | 1/185 (0.5%) | 0/184 (0%) | 0/183 (0%) | 0/155 (0%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 0/168 (0%) | 0/165 (0%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| Varicella | 1/184 (0.5%) | 0/184 (0%) | 1/189 (0.5%) | 0/187 (0%) | 0/187 (0%) | 0/185 (0%) | 0/184 (0%) | 0/183 (0%) | 0/155 (0%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 0/168 (0%) | 0/165 (0%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| Viral infection | 0/184 (0%) | 1/184 (0.5%) | 0/189 (0%) | 2/187 (1.1%) | 1/187 (0.5%) | 0/185 (0%) | 0/184 (0%) | 1/183 (0.5%) | 0/155 (0%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 0/168 (0%) | 1/165 (0.6%) | 0/165 (0%) | 2/161 (1.2%) | ||||||||||||||||
| Acute tonsillitis | 0/184 (0%) | 0/184 (0%) | 0/189 (0%) | 0/187 (0%) | 0/187 (0%) | 0/185 (0%) | 0/184 (0%) | 0/183 (0%) | 0/155 (0%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 1/168 (0.6%) | 0/165 (0%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| Bullous impetigo | 0/184 (0%) | 0/184 (0%) | 0/189 (0%) | 0/187 (0%) | 0/187 (0%) | 0/185 (0%) | 0/184 (0%) | 0/183 (0%) | 0/155 (0%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 1/168 (0.6%) | 0/165 (0%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| Cystitis | 0/184 (0%) | 0/184 (0%) | 0/189 (0%) | 0/187 (0%) | 0/187 (0%) | 0/185 (0%) | 0/184 (0%) | 0/183 (0%) | 0/155 (0%) | 0/163 (0%) | 1/169 (0.6%) | 0/169 (0%) | 0/168 (0%) | 0/165 (0%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| Device related sepsis | 0/184 (0%) | 0/184 (0%) | 0/189 (0%) | 0/187 (0%) | 0/187 (0%) | 0/185 (0%) | 0/184 (0%) | 0/183 (0%) | 0/155 (0%) | 0/163 (0%) | 1/169 (0.6%) | 0/169 (0%) | 0/168 (0%) | 0/165 (0%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| Ear infection | 0/184 (0%) | 0/184 (0%) | 0/189 (0%) | 0/187 (0%) | 0/187 (0%) | 0/185 (0%) | 0/184 (0%) | 0/183 (0%) | 0/155 (0%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 1/168 (0.6%) | 0/165 (0%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| Pharyngotonsillitis | 0/184 (0%) | 0/184 (0%) | 0/189 (0%) | 0/187 (0%) | 0/187 (0%) | 0/185 (0%) | 0/184 (0%) | 0/183 (0%) | 0/155 (0%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 0/168 (0%) | 0/165 (0%) | 1/165 (0.6%) | 0/161 (0%) | ||||||||||||||||
| Renal abscess | 0/184 (0%) | 0/184 (0%) | 0/189 (0%) | 0/187 (0%) | 0/187 (0%) | 0/185 (0%) | 0/184 (0%) | 0/183 (0%) | 1/155 (0.6%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 0/168 (0%) | 0/165 (0%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| Respiratory syncytial virus bronchitis | 0/184 (0%) | 0/184 (0%) | 1/189 (0.5%) | 0/187 (0%) | 0/187 (0%) | 0/185 (0%) | 0/184 (0%) | 1/183 (0.5%) | 0/155 (0%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 0/168 (0%) | 0/165 (0%) | 1/165 (0.6%) | 0/161 (0%) | ||||||||||||||||
| Tracheitis | 0/184 (0%) | 0/184 (0%) | 0/189 (0%) | 0/187 (0%) | 0/187 (0%) | 0/185 (0%) | 0/184 (0%) | 0/183 (0%) | 0/155 (0%) | 0/163 (0%) | 0/169 (0%) | 1/169 (0.6%) | 0/168 (0%) | 0/165 (0%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| Viral myocarditis | 0/184 (0%) | 0/184 (0%) | 0/189 (0%) | 0/187 (0%) | 0/187 (0%) | 0/185 (0%) | 0/184 (0%) | 0/183 (0%) | 0/155 (0%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 0/168 (0%) | 1/165 (0.6%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| Injury, poisoning and procedural complications | ||||||||||||||||||||||||||||||||
| Bone fissure | 0/184 (0%) | 1/184 (0.5%) | 0/189 (0%) | 0/187 (0%) | 0/187 (0%) | 0/185 (0%) | 0/184 (0%) | 0/183 (0%) | 0/155 (0%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 0/168 (0%) | 0/165 (0%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| Concussion | 0/184 (0%) | 0/184 (0%) | 0/189 (0%) | 1/187 (0.5%) | 0/187 (0%) | 0/185 (0%) | 0/184 (0%) | 0/183 (0%) | 0/155 (0%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 0/168 (0%) | 0/165 (0%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| Fall | 0/184 (0%) | 1/184 (0.5%) | 0/189 (0%) | 0/187 (0%) | 0/187 (0%) | 0/185 (0%) | 0/184 (0%) | 2/183 (1.1%) | 0/155 (0%) | 0/163 (0%) | 2/169 (1.2%) | 2/169 (1.2%) | 0/168 (0%) | 1/165 (0.6%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| Foreign body aspiration | 0/184 (0%) | 0/184 (0%) | 0/189 (0%) | 0/187 (0%) | 0/187 (0%) | 1/185 (0.5%) | 0/184 (0%) | 0/183 (0%) | 0/155 (0%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 0/168 (0%) | 0/165 (0%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| Foreign body | 0/184 (0%) | 0/184 (0%) | 0/189 (0%) | 0/187 (0%) | 0/187 (0%) | 0/185 (0%) | 0/184 (0%) | 0/183 (0%) | 0/155 (0%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 1/168 (0.6%) | 0/165 (0%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| Head injury | 1/184 (0.5%) | 0/184 (0%) | 0/189 (0%) | 0/187 (0%) | 1/187 (0.5%) | 0/185 (0%) | 0/184 (0%) | 0/183 (0%) | 0/155 (0%) | 0/163 (0%) | 1/169 (0.6%) | 0/169 (0%) | 0/168 (0%) | 0/165 (0%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| Joint dislocation | 0/184 (0%) | 1/184 (0.5%) | 0/189 (0%) | 0/187 (0%) | 0/187 (0%) | 0/185 (0%) | 0/184 (0%) | 0/183 (0%) | 0/155 (0%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 0/168 (0%) | 0/165 (0%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| Road traffic accident | 0/184 (0%) | 0/184 (0%) | 0/189 (0%) | 0/187 (0%) | 0/187 (0%) | 0/185 (0%) | 0/184 (0%) | 1/183 (0.5%) | 0/155 (0%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 0/168 (0%) | 0/165 (0%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| Thermal burn | 0/184 (0%) | 0/184 (0%) | 0/189 (0%) | 0/187 (0%) | 0/187 (0%) | 0/185 (0%) | 0/184 (0%) | 0/183 (0%) | 1/155 (0.6%) | 0/163 (0%) | 1/169 (0.6%) | 0/169 (0%) | 0/168 (0%) | 0/165 (0%) | 1/165 (0.6%) | 0/161 (0%) | ||||||||||||||||
| Toxicity to various agents | 0/184 (0%) | 0/184 (0%) | 0/189 (0%) | 0/187 (0%) | 0/187 (0%) | 0/185 (0%) | 0/184 (0%) | 0/183 (0%) | 0/155 (0%) | 0/163 (0%) | 1/169 (0.6%) | 0/169 (0%) | 0/168 (0%) | 0/165 (0%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| Accidental exposure to product | 0/184 (0%) | 0/184 (0%) | 0/189 (0%) | 0/187 (0%) | 0/187 (0%) | 0/185 (0%) | 0/184 (0%) | 0/183 (0%) | 1/155 (0.6%) | 0/163 (0%) | 1/169 (0.6%) | 0/169 (0%) | 1/168 (0.6%) | 0/165 (0%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| Investigations | ||||||||||||||||||||||||||||||||
| Acoustic Stimulation Tests | 1/184 (0.5%) | 0/184 (0%) | 0/189 (0%) | 0/187 (0%) | 0/187 (0%) | 0/185 (0%) | 0/184 (0%) | 0/183 (0%) | 0/155 (0%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 0/168 (0%) | 0/165 (0%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| Metabolism and nutrition disorders | ||||||||||||||||||||||||||||||||
| Decreased appetite | 0/184 (0%) | 0/184 (0%) | 0/189 (0%) | 0/187 (0%) | 0/187 (0%) | 0/185 (0%) | 0/184 (0%) | 1/183 (0.5%) | 0/155 (0%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 0/168 (0%) | 0/165 (0%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| Dehydration | 1/184 (0.5%) | 0/184 (0%) | 0/189 (0%) | 1/187 (0.5%) | 1/187 (0.5%) | 1/185 (0.5%) | 1/184 (0.5%) | 0/183 (0%) | 0/155 (0%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 1/168 (0.6%) | 0/165 (0%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| Ketosis | 1/184 (0.5%) | 0/184 (0%) | 0/189 (0%) | 0/187 (0%) | 0/187 (0%) | 0/185 (0%) | 0/184 (0%) | 0/183 (0%) | 0/155 (0%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 0/168 (0%) | 0/165 (0%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| Weight gain poor | 0/184 (0%) | 1/184 (0.5%) | 1/189 (0.5%) | 0/187 (0%) | 0/187 (0%) | 0/185 (0%) | 0/184 (0%) | 0/183 (0%) | 0/155 (0%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 0/168 (0%) | 0/165 (0%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||||||||||||||||||||||
| Fibroma | 0/184 (0%) | 0/184 (0%) | 0/189 (0%) | 0/187 (0%) | 0/187 (0%) | 0/185 (0%) | 1/184 (0.5%) | 0/183 (0%) | 0/155 (0%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 0/168 (0%) | 0/165 (0%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| Neoplasm | 0/184 (0%) | 0/184 (0%) | 0/189 (0%) | 0/187 (0%) | 0/187 (0%) | 0/185 (0%) | 0/184 (0%) | 0/183 (0%) | 0/155 (0%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 0/168 (0%) | 0/165 (0%) | 0/165 (0%) | 1/161 (0.6%) | ||||||||||||||||
| Nervous system disorders | ||||||||||||||||||||||||||||||||
| Febrile convulsion | 1/184 (0.5%) | 1/184 (0.5%) | 0/189 (0%) | 0/187 (0%) | 0/187 (0%) | 0/185 (0%) | 0/184 (0%) | 0/183 (0%) | 1/155 (0.6%) | 1/163 (0.6%) | 0/169 (0%) | 1/169 (0.6%) | 0/168 (0%) | 1/165 (0.6%) | 1/165 (0.6%) | 3/161 (1.9%) | ||||||||||||||||
| Guillain-Barre syndrome | 0/184 (0%) | 0/184 (0%) | 0/189 (0%) | 0/187 (0%) | 0/187 (0%) | 0/185 (0%) | 1/184 (0.5%) | 0/183 (0%) | 0/155 (0%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 0/168 (0%) | 0/165 (0%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| Hypotonia | 0/184 (0%) | 1/184 (0.5%) | 0/189 (0%) | 0/187 (0%) | 0/187 (0%) | 0/185 (0%) | 0/184 (0%) | 1/183 (0.5%) | 0/155 (0%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 0/168 (0%) | 0/165 (0%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| Myoclonic epilepsy | 1/184 (0.5%) | 0/184 (0%) | 0/189 (0%) | 0/187 (0%) | 0/187 (0%) | 0/185 (0%) | 0/184 (0%) | 0/183 (0%) | 0/155 (0%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 0/168 (0%) | 0/165 (0%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| Partial seizures | 0/184 (0%) | 1/184 (0.5%) | 0/189 (0%) | 0/187 (0%) | 0/187 (0%) | 0/185 (0%) | 0/184 (0%) | 0/183 (0%) | 0/155 (0%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 0/168 (0%) | 0/165 (0%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| VIth nerve paralysis | 0/184 (0%) | 0/184 (0%) | 0/189 (0%) | 1/187 (0.5%) | 0/187 (0%) | 0/185 (0%) | 0/184 (0%) | 0/183 (0%) | 0/155 (0%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 0/168 (0%) | 0/165 (0%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| Somnolence | 0/184 (0%) | 1/184 (0.5%) | 0/189 (0%) | 0/187 (0%) | 0/187 (0%) | 0/185 (0%) | 0/184 (0%) | 0/183 (0%) | 0/155 (0%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 0/168 (0%) | 0/165 (0%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| Convulsion | 0/184 (0%) | 0/184 (0%) | 0/189 (0%) | 0/187 (0%) | 0/187 (0%) | 0/185 (0%) | 0/184 (0%) | 0/183 (0%) | 0/155 (0%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 1/168 (0.6%) | 0/165 (0%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| Psychiatric disorders | ||||||||||||||||||||||||||||||||
| Affective disorder | 0/184 (0%) | 0/184 (0%) | 0/189 (0%) | 0/187 (0%) | 0/187 (0%) | 0/185 (0%) | 0/184 (0%) | 0/183 (0%) | 0/155 (0%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 0/168 (0%) | 1/165 (0.6%) | 0/165 (0%) | 1/161 (0.6%) | ||||||||||||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||||||||||||||||||
| Asthma | 1/184 (0.5%) | 0/184 (0%) | 1/189 (0.5%) | 1/187 (0.5%) | 1/187 (0.5%) | 0/185 (0%) | 0/184 (0%) | 0/183 (0%) | 0/155 (0%) | 1/163 (0.6%) | 0/169 (0%) | 0/169 (0%) | 0/168 (0%) | 0/165 (0%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| Dyspnoea | 0/184 (0%) | 0/184 (0%) | 0/189 (0%) | 0/187 (0%) | 1/187 (0.5%) | 0/185 (0%) | 0/184 (0%) | 0/183 (0%) | 0/155 (0%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 0/168 (0%) | 0/165 (0%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| Respiratory distress | 0/184 (0%) | 0/184 (0%) | 0/189 (0%) | 0/187 (0%) | 1/187 (0.5%) | 0/185 (0%) | 0/184 (0%) | 0/183 (0%) | 0/155 (0%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 0/168 (0%) | 0/165 (0%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| Adenoidal hypertrophy | 0/184 (0%) | 0/184 (0%) | 0/189 (0%) | 0/187 (0%) | 0/187 (0%) | 0/185 (0%) | 0/184 (0%) | 0/183 (0%) | 0/155 (0%) | 1/163 (0.6%) | 0/169 (0%) | 0/169 (0%) | 1/168 (0.6%) | 0/165 (0%) | 1/165 (0.6%) | 0/161 (0%) | ||||||||||||||||
| Skin and subcutaneous tissue disorders | ||||||||||||||||||||||||||||||||
| Angioedema | 0/184 (0%) | 1/184 (0.5%) | 0/189 (0%) | 0/187 (0%) | 0/187 (0%) | 0/185 (0%) | 0/184 (0%) | 0/183 (0%) | 0/155 (0%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 0/168 (0%) | 0/165 (0%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| Psoriasis | 0/184 (0%) | 0/184 (0%) | 0/189 (0%) | 0/187 (0%) | 0/187 (0%) | 0/185 (0%) | 1/184 (0.5%) | 0/183 (0%) | 0/155 (0%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 0/168 (0%) | 0/165 (0%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| Rash | 0/184 (0%) | 0/184 (0%) | 0/189 (0%) | 0/187 (0%) | 0/187 (0%) | 0/185 (0%) | 1/184 (0.5%) | 0/183 (0%) | 0/155 (0%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 0/168 (0%) | 0/165 (0%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| Surgical and medical procedures | ||||||||||||||||||||||||||||||||
| Cleft palate repair | 0/184 (0%) | 0/184 (0%) | 0/189 (0%) | 0/187 (0%) | 0/187 (0%) | 0/185 (0%) | 0/184 (0%) | 0/183 (0%) | 1/155 (0.6%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 0/168 (0%) | 0/165 (0%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
Other (Not Including Serious) Adverse Events |
||||||||||||||||||||||||||||||||
| B+OMV (Group I) | B+½ OMV (Group II) | B+1/4 OMV (Group III) | B (Group IV) | ½ (B+OMV) (Group V) | PH2 B+OMV (Group VI) | MenC (Group VII) | Par+B+OMV (Group VIII) | B+OMV (Group I) Booster Phase | B+½ OMV (Group II) Booster Phase | B+1/4 OMV (Group III) Booster Phase | B (Group IV) Booster Phase | ½ (B+OMV) (Group V) Booster Phase | PH2 B+OMV (Group VI) Booster Phase | MenC (Group VII) Booster Phase | Par+B+OMV (Group VIII) Booster Phase | |||||||||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 181/184 (98.4%) | 183/184 (99.5%) | 186/189 (98.4%) | 183/187 (97.9%) | 180/187 (96.3%) | 180/185 (97.3%) | 175/184 (95.1%) | 175/183 (95.6%) | 151/155 (97.4%) | 159/163 (97.5%) | 162/169 (95.9%) | 152/169 (89.9%) | 154/168 (91.7%) | 156/165 (94.5%) | 155/165 (93.9%) | 150/161 (93.2%) | ||||||||||||||||
| Gastrointestinal disorders | ||||||||||||||||||||||||||||||||
| Diarrhoea | 84/184 (45.7%) | 87/184 (47.3%) | 80/189 (42.3%) | 67/187 (35.8%) | 80/187 (42.8%) | 81/185 (43.8%) | 74/184 (40.2%) | 73/183 (39.9%) | 31/155 (20%) | 37/163 (22.7%) | 39/169 (23.1%) | 47/169 (27.8%) | 34/168 (20.2%) | 31/165 (18.8%) | 40/165 (24.2%) | 34/161 (21.1%) | ||||||||||||||||
| Vomiting | 38/184 (20.7%) | 37/184 (20.1%) | 42/189 (22.2%) | 32/187 (17.1%) | 36/187 (19.3%) | 43/185 (23.2%) | 34/184 (18.5%) | 46/183 (25.1%) | 6/155 (3.9%) | 13/163 (8%) | 7/169 (4.1%) | 7/169 (4.1%) | 10/168 (6%) | 10/165 (6.1%) | 15/165 (9.1%) | 20/161 (12.4%) | ||||||||||||||||
| General disorders | ||||||||||||||||||||||||||||||||
| Crying | 122/184 (66.3%) | 135/184 (73.4%) | 137/189 (72.5%) | 99/187 (52.9%) | 125/187 (66.8%) | 141/185 (76.2%) | 87/184 (47.3%) | 112/183 (61.2%) | 74/155 (47.7%) | 64/163 (39.3%) | 69/169 (40.8%) | 46/169 (27.2%) | 71/168 (42.3%) | 82/165 (49.7%) | 85/165 (51.5%) | 50/161 (31.1%) | ||||||||||||||||
| Injection site erythema | 151/184 (82.1%) | 150/184 (81.5%) | 155/189 (82%) | 132/187 (70.6%) | 131/187 (70.1%) | 150/185 (81.1%) | 119/184 (64.7%) | 132/183 (72.1%) | 97/155 (62.6%) | 107/163 (65.6%) | 120/169 (71%) | 83/169 (49.1%) | 89/168 (53%) | 96/165 (58.2%) | 110/165 (66.7%) | 88/161 (54.7%) | ||||||||||||||||
| Injection site induration | 141/184 (76.6%) | 139/184 (75.5%) | 141/189 (74.6%) | 126/187 (67.4%) | 130/187 (69.5%) | 130/185 (70.3%) | 122/184 (66.3%) | 126/183 (68.9%) | 81/155 (52.3%) | 90/163 (55.2%) | 105/169 (62.1%) | 71/169 (42%) | 76/168 (45.2%) | 81/165 (49.1%) | 97/165 (58.8%) | 70/161 (43.5%) | ||||||||||||||||
| Injection site pain | 150/184 (81.5%) | 157/184 (85.3%) | 139/189 (73.5%) | 101/187 (54%) | 131/187 (70.1%) | 152/185 (82.2%) | 105/184 (57.1%) | 119/183 (65%) | 121/155 (78.1%) | 110/163 (67.5%) | 126/169 (74.6%) | 92/169 (54.4%) | 111/168 (66.1%) | 116/165 (70.3%) | 125/165 (75.8%) | 97/161 (60.2%) | ||||||||||||||||
| Pyrexia | 136/184 (73.9%) | 127/184 (69%) | 122/189 (64.6%) | 71/187 (38%) | 114/187 (61%) | 126/185 (68.1%) | 62/184 (33.7%) | 78/183 (42.6%) | 86/155 (55.5%) | 94/163 (57.7%) | 70/169 (41.4%) | 49/169 (29%) | 85/168 (50.6%) | 72/165 (43.6%) | 92/165 (55.8%) | 59/161 (36.6%) | ||||||||||||||||
| Injection site swelling | 97/184 (52.7%) | 94/184 (51.1%) | 103/189 (54.5%) | 80/187 (42.8%) | 88/187 (47.1%) | 100/185 (54.1%) | 75/184 (40.8%) | 77/183 (42.1%) | 57/155 (36.8%) | 63/163 (38.7%) | 76/169 (45%) | 46/169 (27.2%) | 53/168 (31.5%) | 57/165 (34.5%) | 65/165 (39.4%) | 50/161 (31.1%) | ||||||||||||||||
| Infections and infestations | ||||||||||||||||||||||||||||||||
| Bronchitis | 34/184 (18.5%) | 34/184 (18.5%) | 40/189 (21.2%) | 31/187 (16.6%) | 31/187 (16.6%) | 43/185 (23.2%) | 34/184 (18.5%) | 35/183 (19.1%) | 25/155 (16.1%) | 18/163 (11%) | 25/169 (14.8%) | 28/169 (16.6%) | 28/168 (16.7%) | 19/165 (11.5%) | 35/165 (21.2%) | 17/161 (10.6%) | ||||||||||||||||
| Conjunctivitis | 14/184 (7.6%) | 13/184 (7.1%) | 14/189 (7.4%) | 13/187 (7%) | 15/187 (8%) | 22/185 (11.9%) | 10/184 (5.4%) | 17/183 (9.3%) | 7/155 (4.5%) | 7/163 (4.3%) | 5/169 (3%) | 13/169 (7.7%) | 8/168 (4.8%) | 7/165 (4.2%) | 6/165 (3.6%) | 10/161 (6.2%) | ||||||||||||||||
| Ear infection | 10/184 (5.4%) | 5/184 (2.7%) | 10/189 (5.3%) | 6/187 (3.2%) | 7/187 (3.7%) | 12/185 (6.5%) | 9/184 (4.9%) | 7/183 (3.8%) | 8/155 (5.2%) | 4/163 (2.5%) | 2/169 (1.2%) | 5/169 (3%) | 9/168 (5.4%) | 7/165 (4.2%) | 11/165 (6.7%) | 4/161 (2.5%) | ||||||||||||||||
| Exanthema subitum | 9/184 (4.9%) | 18/184 (9.8%) | 17/189 (9%) | 17/187 (9.1%) | 19/187 (10.2%) | 13/185 (7%) | 20/184 (10.9%) | 11/183 (6%) | 6/155 (3.9%) | 7/163 (4.3%) | 8/169 (4.7%) | 5/169 (3%) | 5/168 (3%) | 6/165 (3.6%) | 7/165 (4.2%) | 10/161 (6.2%) | ||||||||||||||||
| Gastroenteritis | 10/184 (5.4%) | 11/184 (6%) | 6/189 (3.2%) | 9/187 (4.8%) | 6/187 (3.2%) | 13/185 (7%) | 7/184 (3.8%) | 8/183 (4.4%) | 5/155 (3.2%) | 4/163 (2.5%) | 8/169 (4.7%) | 11/169 (6.5%) | 12/168 (7.1%) | 15/165 (9.1%) | 9/165 (5.5%) | 7/161 (4.3%) | ||||||||||||||||
| Nasopharyngitis | 20/184 (10.9%) | 22/184 (12%) | 25/189 (13.2%) | 17/187 (9.1%) | 19/187 (10.2%) | 24/185 (13%) | 16/184 (8.7%) | 19/183 (10.4%) | 15/155 (9.7%) | 10/163 (6.1%) | 18/169 (10.7%) | 11/169 (6.5%) | 14/168 (8.3%) | 15/165 (9.1%) | 14/165 (8.5%) | 7/161 (4.3%) | ||||||||||||||||
| Pharyngitis | 21/184 (11.4%) | 18/184 (9.8%) | 15/189 (7.9%) | 21/187 (11.2%) | 25/187 (13.4%) | 15/185 (8.1%) | 18/184 (9.8%) | 19/183 (10.4%) | 11/155 (7.1%) | 16/163 (9.8%) | 13/169 (7.7%) | 14/169 (8.3%) | 22/168 (13.1%) | 15/165 (9.1%) | 16/165 (9.7%) | 15/161 (9.3%) | ||||||||||||||||
| Rhinitis | 21/184 (11.4%) | 14/184 (7.6%) | 12/189 (6.3%) | 19/187 (10.2%) | 21/187 (11.2%) | 26/185 (14.1%) | 20/184 (10.9%) | 12/183 (6.6%) | 7/155 (4.5%) | 9/163 (5.5%) | 8/169 (4.7%) | 11/169 (6.5%) | 10/168 (6%) | 8/165 (4.8%) | 6/165 (3.6%) | 6/161 (3.7%) | ||||||||||||||||
| Tonsillitis | 6/184 (3.3%) | 3/184 (1.6%) | 2/189 (1.1%) | 12/187 (6.4%) | 7/187 (3.7%) | 5/185 (2.7%) | 5/184 (2.7%) | 4/183 (2.2%) | 6/155 (3.9%) | 10/163 (6.1%) | 4/169 (2.4%) | 8/169 (4.7%) | 5/168 (3%) | 8/165 (4.8%) | 6/165 (3.6%) | 9/161 (5.6%) | ||||||||||||||||
| Upper respiratory tract infection | 13/184 (7.1%) | 13/184 (7.1%) | 10/189 (5.3%) | 10/187 (5.3%) | 8/187 (4.3%) | 12/185 (6.5%) | 9/184 (4.9%) | 9/183 (4.9%) | 8/155 (5.2%) | 7/163 (4.3%) | 8/169 (4.7%) | 9/169 (5.3%) | 7/168 (4.2%) | 9/165 (5.5%) | 8/165 (4.8%) | 5/161 (3.1%) | ||||||||||||||||
| Varicella | 5/184 (2.7%) | 10/184 (5.4%) | 2/189 (1.1%) | 5/187 (2.7%) | 7/187 (3.7%) | 5/185 (2.7%) | 5/184 (2.7%) | 5/183 (2.7%) | 0/155 (0%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 0/168 (0%) | 0/165 (0%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| Viral infection | 19/184 (10.3%) | 27/184 (14.7%) | 23/189 (12.2%) | 24/187 (12.8%) | 24/187 (12.8%) | 17/185 (9.2%) | 16/184 (8.7%) | 21/183 (11.5%) | 12/155 (7.7%) | 14/163 (8.6%) | 6/169 (3.6%) | 16/169 (9.5%) | 18/168 (10.7%) | 9/165 (5.5%) | 12/165 (7.3%) | 11/161 (6.8%) | ||||||||||||||||
| Nervous system disorders | ||||||||||||||||||||||||||||||||
| Somnolence | 145/184 (78.8%) | 149/184 (81%) | 146/189 (77.2%) | 131/187 (70.1%) | 142/187 (75.9%) | 143/185 (77.3%) | 113/184 (61.4%) | 134/183 (73.2%) | 76/155 (49%) | 90/163 (55.2%) | 90/169 (53.3%) | 63/169 (37.3%) | 86/168 (51.2%) | 88/165 (53.3%) | 100/165 (60.6%) | 80/161 (49.7%) | ||||||||||||||||
| Psychiatric disorders | ||||||||||||||||||||||||||||||||
| Eating disorder | 105/184 (57.1%) | 106/184 (57.6%) | 104/189 (55%) | 84/187 (44.9%) | 112/187 (59.9%) | 119/185 (64.3%) | 63/184 (34.2%) | 93/183 (50.8%) | 74/155 (47.7%) | 77/163 (47.2%) | 79/169 (46.7%) | 52/169 (30.8%) | 70/168 (41.7%) | 80/165 (48.5%) | 72/165 (43.6%) | 66/161 (41%) | ||||||||||||||||
| Irritability | 157/184 (85.3%) | 159/184 (86.4%) | 155/189 (82%) | 139/187 (74.3%) | 151/187 (80.7%) | 153/185 (82.7%) | 121/184 (65.8%) | 137/183 (74.9%) | 116/155 (74.8%) | 111/163 (68.1%) | 112/169 (66.3%) | 86/169 (50.9%) | 116/168 (69%) | 115/165 (69.7%) | 126/165 (76.4%) | 96/161 (59.6%) | ||||||||||||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||||||||||||||||||
| Cough | 22/184 (12%) | 21/184 (11.4%) | 9/189 (4.8%) | 19/187 (10.2%) | 13/187 (7%) | 19/185 (10.3%) | 12/184 (6.5%) | 10/183 (5.5%) | 5/155 (3.2%) | 12/163 (7.4%) | 11/169 (6.5%) | 9/169 (5.3%) | 11/168 (6.5%) | 8/165 (4.8%) | 10/165 (6.1%) | 7/161 (4.3%) | ||||||||||||||||
| Skin and subcutaneous tissue disorders | ||||||||||||||||||||||||||||||||
| Dermatitis | 10/184 (5.4%) | 3/184 (1.6%) | 7/189 (3.7%) | 0/187 (0%) | 6/187 (3.2%) | 2/185 (1.1%) | 13/184 (7.1%) | 9/183 (4.9%) | 0/155 (0%) | 0/163 (0%) | 0/169 (0%) | 0/169 (0%) | 0/168 (0%) | 0/165 (0%) | 0/165 (0%) | 0/161 (0%) | ||||||||||||||||
| Rash | 15/184 (8.2%) | 18/184 (9.8%) | 15/189 (7.9%) | 18/187 (9.6%) | 24/187 (12.8%) | 26/185 (14.1%) | 16/184 (8.7%) | 19/183 (10.4%) | 8/155 (5.2%) | 6/163 (3.7%) | 11/169 (6.5%) | 2/169 (1.2%) | 9/168 (5.4%) | 6/165 (3.6%) | 12/165 (7.3%) | 7/161 (4.3%) | ||||||||||||||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Novartis Vaccines |
|---|---|
| Organization | Novartis Vaccines |
| Phone | |
| RegistryContactVaccinesUS@novartis.com |
Responsible Party:
Novartis Vaccines
ClinicalTrials.gov Identifier:
NCT00937521
Other Study ID Numbers:
- V72P16
- 2009-010106-11
First Posted:
Jul 13, 2009
Last Update Posted:
Apr 7, 2015
Last Verified:
Mar 1, 2015