A Study to Assess the Immunogenicity and Safety of GSK Biologicals' Infanrix-IPV/Hib Vaccine Administered as a Three-dose Vaccination Course at 3, 4.5 and 6 Months of Age and a Booster Dose at 18 Months of Age in Healthy Infants in Russia
Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT02858440
Collaborator
(none)
235
5
1
26
47
1.8
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the immune response, safety and reactogenicity after receiving combined DTPa-IPV/Hib vaccine when administered as a three-dose primary vaccination course at 3, 4.5 and 6 months of age and as a booster dose at 18 months of age in Russian healthy children according to the Russian immunisation schedule
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
235 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Immunogenicity and Safety of GSK Biologicals' Combined Diphtheria-tetanus-acellular Pertussis-inactivated Poliovirus and Haemophilus Influenzae Type b (DTPa-IPV/Hib) Conjugate Vaccine
Actual Study Start Date
:
Sep 13, 2016
Actual Primary Completion Date
:
Oct 24, 2017
Actual Study Completion Date
:
Nov 13, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: DTPa-IPV/Hib Group All subjects receive three doses of primary vaccination of the study vaccine, Infanrix-IPV/Hib (DTPa-IPV/Hib), at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine is administered intramuscularly into the upper side of the thigh on the right/left side. |
Biological: Infanrix-IPV/Hib
Subjects receive Infanrix-IPV/Hib three-dose primary vaccination course at 3, 4.5 and 6 months of age and a booster dose at 18 months of age. The vaccine is administered intramuscularly into the upper side of the thigh on the right/left side.
|
Outcome Measures
Primary Outcome Measures
- Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T), Post Primary Vaccination [At Month 4 (i.e. one month after 3rd dose of primary vaccination)]
A seroprotected subject is a subject whose anti-D and anti-T antibody concentration was greater than or equal to (≥) 0.1 International Units per milliliter (IU/mL).
- Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3, Post Primary Vaccination [At Month 4 (i.e. one month after 3rd dose of primary vaccination)]
A seroprotected subject is a subject whose anti-poliovirus types 1, 2 and 3 antibody titer was ≥ 8 ED50.
- Number of Seroprotected Subjects for Anti-polyribosyl Ribitol Phosphate (Anti-PRP), Post Primary Vaccination [At Month 4 (i.e. one month after 3rd dose of primary vaccination)]
A seroprotected subject is a subject whose anti-PRP antibody concentration was ≥ 0.15 micrograms per milliliter (µg/mL).
- Number of Seropositive Subjects for Anti-pertussis (Anti- PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN), Post Primary Vaccination [At Month 4 (i.e. one month after 3rd dose of primary vaccination)]
A seropositive subject is a subject whose antibody concentration was ≥ 2.046 IU/mL for anti-FHA, ≥ 2.187 IU/mL for anti-PRN and ≥ 2.693 IU/mL for anti-PT.
Secondary Outcome Measures
- Number of Seroprotected Subjects for Anti-D and Anti-T, Post Booster Vaccination [At Month 16 (i.e. one month after booster vaccination)]
A seroprotected subject is a subject whose anti-D and anti-T antibody concentration was ≥ 0.1 IU/mL.
- Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3, Post Booster Vaccination [At Month 16 (i.e. one month after booster vaccination)]
A seroprotected subject is a subject whose anti-poliovirus types 1, 2 and 3 antibody titer was ≥ 8 ED50.
- Number of Seroprotected Subjects for Anti-PRP, Post Booster Vaccination [At Month 16 (i.e. one month after booster vaccination)]
A seroprotected subject is a subject whose anti-PRP antibody concentration was ≥ 0.15 µg/mL.
- Number of Seropositive Subjects for Anti- PT, Anti-FHA and Anti-PRN, Post Booster Vaccination [At Month 16 (i.e. one month after booster vaccination)]
A seropositive subject is a subject whose antibody concentration was ≥ 2.046 IU/mL for anti-FHA, ≥ 2.187 IU/mL for anti-PRN and ≥ 2.693 IU/mL for anti-PT.
- Antibody Concentrations for Anti-D and Anti-T, Post Primary Vaccination [At Month 4 (i.e. one month after 3rd dose of primary vaccination)]
The antibody concentrations for anti-D and anti-T were presented as geometric mean concentrations (GMCs) and expressed as IU/mL.
- Antibody Concentrations for Anti-D and Anti-T, Post Booster Vaccination [At Month 16 (i.e. one month after booster vaccination)]
The antibody concentrations for anti-D and anti-T were presented as geometric mean concentrations (GMCs) and expressed as IU/mL.
- Antibody Titers for Anti-polio Types 1, 2 and 3, Post Primary Vaccination [At Month 4 (i.e. one month after 3rd dose of primary vaccination)]
The antibody titers for anti-polio types 1, 2 and 3 were presented as geometric mean titres (GMTs).
- Antibody Titers for Anti-polio Types 1, 2 and 3, Post Booster Vaccination [At Month 16 (i.e. one month after booster vaccination)]
The antibody titers for anti-polio types 1, 2 and 3 were presented as geometric mean titres (GMTs).
- Antibody Concentration for Anti-PRP, Post Primary Vaccination [At Month 4 (i.e. one month after 3rd dose of primary vaccination)]
The antibody concentrations for anti-PRP were presented as geometric mean concentrations (GMCs) and expressed as µg/mL.
- Antibody Concentration for Anti-PRP, Post Booster Vaccination [At Month 16 (i.e. one month after booster vaccination)]
The antibody concentrations for anti-PRP were presented as geometric mean concentrations (GMCs) and expressed as µg/mL.
- Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN, Post Primary Vaccination [At Month 4 (i.e. one month after 3rd dose of primary vaccination)]
The antibody concentrations for anti-PT, anti-FHA and anti-PRN were presented as GMCs and expressed as IU/mL.
- Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN, Post Booster Vaccination [At Month 16 (i.e. one month after booster vaccination)]
The antibody concentrations for anti-PT, anti-FHA and anti-PRN were presented as GMCs and expressed as IU/mL.
- Number of Subjects With Any Solicited Local Adverse Events (AEs) Following Each Dose of Primary Vaccination [During the 4-day (Days 0-3) follow-up period after each primary vaccination dose (i.e. at Day 0, at Month 1.5 and at Month 3)]
The solicited local AEs assessed were pain, redness and swelling at injection site. Any = Occurrence of the AE regardless of the intensity grade.
- Number of Subjects With Any Solicited Local AEs Following Booster Vaccination [During the 4-day (Days 0-3) follow-up period after booster vaccination dose (i.e. at Month 15)]
The solicited local AEs assessed were pain, redness and swelling at injection site. Any = Occurrence of the AE regardless of the intensity grade.
- Number of Subjects With Any Solicited General AEs Following Each Dose of Primary Vaccination [During the 4-day (Days 0-3) follow-up period after each primary vaccination dose (i.e. at Day 0, at Month 1.5 and at Month 3)]
The solicited general AEs assessed were drowsiness, irritability/fussiness, loss of appetite and fever. Any = Occurrence of the AE regardless of the intensity grade. Any fever = Fever (axillary) ≥ 37.5°C.
- Number of Subjects With Any Solicited General AEs Following Booster Vaccination [During the 4-day (Days 0-3) follow-up period after booster vaccination dose (i.e. at Month 15)]
The solicited general AEs assessed were drowsiness, irritability/fussiness, loss of appetite and fever. Any = Occurrence of the AE regardless of the intensity grade. Any fever = Fever (axillary) ≥ 37.5°C.
- Number of Subjects With Unsolicited AEs Following Each Dose of Primary Vaccination [During the 31-day (Days 0-30) follow-up period after each primary vaccination dose (i.e. at Day 0, at Month 1.5 and at Month 3)]
An unsolicited AE was defined as any AE reported in addition to those solicited during the clinical study and any solicited AE with onset outside the specified period of follow-up for solicited AEs. Any = Occurrence of the AE regardless of the intensity grade.
- Number of Subjects With Unsolicited AEs Following Booster Vaccination [During the 31-day (Days 0-30) follow-up period after booster vaccination dose (i.e. at Month 15)]
An unsolicited AE was defined as any AE reported in addition to those solicited during the clinical study and any solicited AE with onset outside the specified period of follow-up for solicited AEs. Any = Occurrence of the AE regardless of the intensity grade.
- Number of Subjects With Serious Adverse Events (SAEs) [During the entire study period (i.e. from Day 0 until Month 16)]
The SAEs assessed included any untoward medical occurrences that resulted in death, were life threatening, required hospitalisation or prolongation of existing hospitalisation or resulted in disability/incapacity. Any = Occurrence of the AE regardless of the intensity grade.
Eligibility Criteria
Criteria
Ages Eligible for Study:
3 Months
to 19 Months
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Subjects' parent(s)/Legally Acceptable Representatives [LARs] who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
-
A male or female child between 3 and 4 months of age at the time of the first vaccination.
-
Written informed consent obtained from the parents/LARs of the subject prior to performing any study specific procedure.
-
Healthy subjects as established by medical history and clinical examination before entering into the study.
-
Born full-term.
Exclusion Criteria:
-
Child in care
-
Use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before the first dose of study vaccine, or planned use during the study period.
-
Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
-
Chronic administration of immunosuppressants or other immune-modifying drugs during the period starting since birth. For corticosteroids, this will mean prednisone ≥ 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
-
Administration of long-acting immune-modifying drugs at any time during the study period
-
Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose and ending 30 days after the last dose of vaccine administration, with the exception of hepatitis B and other vaccines given as part of the national immunisation schedule and as part of routine vaccination practice, that are allowed at any time during the study period. Seasonal or pandemic influenza vaccine can be given at any time during the study, and according to the Summary of Product Characteristics and national recommendations.
-
Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product
-
Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis and Hib diseases.
-
History of diphtheria, tetanus, pertussis, poliomyelitis and Hib diseases.
-
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
-
Family history of congenital or hereditary immunodeficiency.
-
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
-
Major congenital defects.
-
Serious chronic illness.
-
History of any neurological disorders or seizures.
-
Acute disease and/or fever at the time of enrolment.
-
Fever is defined as temperature ≥37.5°C for oral, axillary or tympanic route, or ≥38.0°C for rectal route.
-
Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
-
Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | GSK Investigational Site | Barnaul | Russian Federation | 656056 | |
| 2 | GSK Investigational Site | Ekaterinburg | Russian Federation | 620131 | |
| 3 | GSK Investigational Site | Murmansk | Russian Federation | 183038 | |
| 4 | GSK Investigational Site | St.Petersburg | Russian Federation | 191025 | |
| 5 | GSK Investigational Site | Tomsk | Russian Federation | 634 050 |
Sponsors and Collaborators
- GlaxoSmithKline
Investigators
- Study Director: GSK Clinical Trials, GlaxoSmithKline
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT02858440
Other Study ID Numbers:
- 116194
- 2013-005577-43
First Posted:
Aug 8, 2016
Last Update Posted:
Sep 24, 2019
Last Verified:
Sep 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by GlaxoSmithKline
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | DTPa-IPV/Hib Group |
|---|---|
| Arm/Group Description | All subjects received three doses of primary vaccination of the study vaccine, Infanrix-IPV/Hib (DTPa-IPV/Hib), at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side. |
| Period Title: Overall Study | |
| STARTED | 235 |
| COMPLETED | 223 |
| NOT COMPLETED | 12 |
Baseline Characteristics
| Arm/Group Title | DTPa-IPV/Hib Group |
|---|---|
| Arm/Group Description | All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side. |
| Overall Participants | 235 |
| Age (Weeks) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [Weeks] |
14.1
(1.2)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
111
47.2%
|
| Male |
124
52.8%
|
| Race/Ethnicity, Customized (Count of Participants) | |
| White - Caucasian / European Heritage |
235
100%
|
Outcome Measures
| Title | Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T), Post Primary Vaccination |
|---|---|
| Description | A seroprotected subject is a subject whose anti-D and anti-T antibody concentration was greater than or equal to (≥) 0.1 International Units per milliliter (IU/mL). |
| Time Frame | At Month 4 (i.e. one month after 3rd dose of primary vaccination) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The According-to-protocol (ATP) cohort for analysis of immunogenicity of the primary epoch included all evaluable subjects who complied with protocol and for whom assay results were available for antibodies against at least one study vaccine antigen component one month after Dose 3. |
| Arm/Group Title | DTPa-IPV/Hib Group |
|---|---|
| Arm/Group Description | All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side. |
| Measure Participants | 176 |
| Anti-D antibody ≥ 0.1 IU/mL |
176
74.9%
|
| Anti-T antibody ≥ 0.1 IU/mL |
176
74.9%
|
| Title | Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3, Post Primary Vaccination |
|---|---|
| Description | A seroprotected subject is a subject whose anti-poliovirus types 1, 2 and 3 antibody titer was ≥ 8 ED50. |
| Time Frame | At Month 4 (i.e. one month after 3rd dose of primary vaccination) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The According-to-protocol (ATP) cohort for analysis of immunogenicity of the primary epoch included all evaluable subjects who complied with protocol and for whom assay results were available for antibodies against at least one study vaccine antigen component one month after Dose 3. |
| Arm/Group Title | DTPa-IPV/Hib Group |
|---|---|
| Arm/Group Description | All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side. |
| Measure Participants | 151 |
| Anti-Polio 1 antibody ≥ 8 ED50 |
151
64.3%
|
| Anti-Polio 2 antibody ≥ 8 ED50 |
151
64.3%
|
| Anti-Polio 3 antibody ≥ 8 ED50 |
150
63.8%
|
| Title | Number of Seroprotected Subjects for Anti-polyribosyl Ribitol Phosphate (Anti-PRP), Post Primary Vaccination |
|---|---|
| Description | A seroprotected subject is a subject whose anti-PRP antibody concentration was ≥ 0.15 micrograms per milliliter (µg/mL). |
| Time Frame | At Month 4 (i.e. one month after 3rd dose of primary vaccination) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The According-to-protocol (ATP) cohort for analysis of immunogenicity of the primary epoch included all evaluable subjects who complied with protocol and for whom assay results were available for antibodies against at least one study vaccine antigen component one month after Dose 3. |
| Arm/Group Title | DTPa-IPV/Hib Group |
|---|---|
| Arm/Group Description | All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side. |
| Measure Participants | 182 |
| Count of Participants [Participants] |
179
76.2%
|
| Title | Number of Seropositive Subjects for Anti-pertussis (Anti- PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN), Post Primary Vaccination |
|---|---|
| Description | A seropositive subject is a subject whose antibody concentration was ≥ 2.046 IU/mL for anti-FHA, ≥ 2.187 IU/mL for anti-PRN and ≥ 2.693 IU/mL for anti-PT. |
| Time Frame | At Month 4 (i.e. one month after 3rd dose of primary vaccination) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The According-to-protocol (ATP) cohort for analysis of immunogenicity of the primary epoch included all evaluable subjects who complied with protocol and for whom assay results were available for antibodies against at least one study vaccine antigen component one month after Dose 3. |
| Arm/Group Title | DTPa-IPV/Hib Group |
|---|---|
| Arm/Group Description | All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side. |
| Measure Participants | 176 |
| Anti-FHA antibody ≥ 2.046 IU/mL |
175
74.5%
|
| Anti-PRN antibody ≥ 2.187 IU/mL |
175
74.5%
|
| Anti-PT antibody ≥ 2.693 IU/mL |
174
74%
|
| Title | Number of Seroprotected Subjects for Anti-D and Anti-T, Post Booster Vaccination |
|---|---|
| Description | A seroprotected subject is a subject whose anti-D and anti-T antibody concentration was ≥ 0.1 IU/mL. |
| Time Frame | At Month 16 (i.e. one month after booster vaccination) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The ATP cohort for analysis of immunogenicity of the booster epoch included all evaluable subjects who complied with protocol and for whom assay results were available for antibodies against at least one study vaccine antigen component one month after the booster dose. |
| Arm/Group Title | DTPa-IPV/Hib Group |
|---|---|
| Arm/Group Description | All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side. |
| Measure Participants | 188 |
| anti-D antibody |
188
80%
|
| anti-T antibody |
188
80%
|
| Title | Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3, Post Booster Vaccination |
|---|---|
| Description | A seroprotected subject is a subject whose anti-poliovirus types 1, 2 and 3 antibody titer was ≥ 8 ED50. |
| Time Frame | At Month 16 (i.e. one month after booster vaccination) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The ATP cohort for analysis of immunogenicity of the booster epoch included all evaluable subjects who complied with protocol and for whom assay results were available for antibodies against at least one study vaccine antigen component one month after the booster dose. |
| Arm/Group Title | DTPa-IPV/Hib Group |
|---|---|
| Arm/Group Description | All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side. |
| Measure Participants | 176 |
| anti-Polio 1 antibody |
176
74.9%
|
| anti-Polio 2 antibody |
169
71.9%
|
| anti-Polio 3 antibody |
167
71.1%
|
| Title | Number of Seroprotected Subjects for Anti-PRP, Post Booster Vaccination |
|---|---|
| Description | A seroprotected subject is a subject whose anti-PRP antibody concentration was ≥ 0.15 µg/mL. |
| Time Frame | At Month 16 (i.e. one month after booster vaccination) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The ATP cohort for analysis of immunogenicity of the booster epoch included all evaluable subjects who complied with protocol and for whom assay results were available for antibodies against at least one study vaccine antigen component one month after the booster dose. |
| Arm/Group Title | DTPa-IPV/Hib Group |
|---|---|
| Arm/Group Description | All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side. |
| Measure Participants | 188 |
| Count of Participants [Participants] |
188
80%
|
| Title | Number of Seropositive Subjects for Anti- PT, Anti-FHA and Anti-PRN, Post Booster Vaccination |
|---|---|
| Description | A seropositive subject is a subject whose antibody concentration was ≥ 2.046 IU/mL for anti-FHA, ≥ 2.187 IU/mL for anti-PRN and ≥ 2.693 IU/mL for anti-PT. |
| Time Frame | At Month 16 (i.e. one month after booster vaccination) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The ATP cohort for analysis of immunogenicity of the booster epoch included all evaluable subjects who complied with protocol and for whom assay results were available for antibodies against at least one study vaccine antigen component one month after the booster dose. |
| Arm/Group Title | DTPa-IPV/Hib Group |
|---|---|
| Arm/Group Description | All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side. |
| Measure Participants | 188 |
| anti-PT antibody |
188
80%
|
| anti-FHA antibody |
188
80%
|
| anti-PRN antibody |
187
79.6%
|
| Title | Antibody Concentrations for Anti-D and Anti-T, Post Primary Vaccination |
|---|---|
| Description | The antibody concentrations for anti-D and anti-T were presented as geometric mean concentrations (GMCs) and expressed as IU/mL. |
| Time Frame | At Month 4 (i.e. one month after 3rd dose of primary vaccination) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The According-to-protocol (ATP) cohort for analysis of immunogenicity of the primary epoch included all evaluable subjects who complied with protocol and for whom assay results were available for antibodies against at least one study vaccine antigen component one month after Dose 3. |
| Arm/Group Title | DTPa-IPV/Hib Group |
|---|---|
| Arm/Group Description | All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side. |
| Measure Participants | 176 |
| Anti-D antibody |
3.24
|
| Anti-T antibody |
3.14
|
| Title | Antibody Concentrations for Anti-D and Anti-T, Post Booster Vaccination |
|---|---|
| Description | The antibody concentrations for anti-D and anti-T were presented as geometric mean concentrations (GMCs) and expressed as IU/mL. |
| Time Frame | At Month 16 (i.e. one month after booster vaccination) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The ATP cohort for analysis of immunogenicity of the booster epoch included all evaluable subjects who complied with protocol and for whom assay results were available for antibodies against at least one study vaccine antigen component one month after the booster dose. |
| Arm/Group Title | DTPa-IPV/Hib Group |
|---|---|
| Arm/Group Description | All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side. |
| Measure Participants | 188 |
| anti-D antibody |
12.11
|
| anti-T antibody |
8.18
|
| Title | Antibody Titers for Anti-polio Types 1, 2 and 3, Post Primary Vaccination |
|---|---|
| Description | The antibody titers for anti-polio types 1, 2 and 3 were presented as geometric mean titres (GMTs). |
| Time Frame | At Month 4 (i.e. one month after 3rd dose of primary vaccination) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The According-to-protocol (ATP) cohort for analysis of immunogenicity of the primary epoch included all evaluable subjects who complied with protocol and for whom assay results were available for antibodies against at least one study vaccine antigen component one month after Dose 3. |
| Arm/Group Title | DTPa-IPV/Hib Group |
|---|---|
| Arm/Group Description | All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side. |
| Measure Participants | 151 |
| Anti-Polio 1 antibody |
613.9
|
| Anti-Polio 2 antibody |
591.6
|
| Anti-Polio 3 antibody |
827.4
|
| Title | Antibody Titers for Anti-polio Types 1, 2 and 3, Post Booster Vaccination |
|---|---|
| Description | The antibody titers for anti-polio types 1, 2 and 3 were presented as geometric mean titres (GMTs). |
| Time Frame | At Month 16 (i.e. one month after booster vaccination) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The ATP cohort for analysis of immunogenicity of the booster epoch included all evaluable subjects who complied with protocol and for whom assay results were available for antibodies against at least one study vaccine antigen component one month after the booster dose. |
| Arm/Group Title | DTPa-IPV/Hib Group |
|---|---|
| Arm/Group Description | All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side. |
| Measure Participants | 176 |
| anti-Polio 1 antibody |
2185.4
|
| anti-Polio 2 antibody |
2944.1
|
| anti-Polio 3 antibody |
3684.6
|
| Title | Antibody Concentration for Anti-PRP, Post Primary Vaccination |
|---|---|
| Description | The antibody concentrations for anti-PRP were presented as geometric mean concentrations (GMCs) and expressed as µg/mL. |
| Time Frame | At Month 4 (i.e. one month after 3rd dose of primary vaccination) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The According-to-protocol (ATP) cohort for analysis of immunogenicity of the primary epoch included all evaluable subjects who complied with protocol and for whom assay results were available for antibodies against at least one study vaccine antigen component one month after Dose 3. |
| Arm/Group Title | DTPa-IPV/Hib Group |
|---|---|
| Arm/Group Description | All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side. |
| Measure Participants | 182 |
| Geometric Mean (95% Confidence Interval) [µg/mL] |
2.97
|
| Title | Antibody Concentration for Anti-PRP, Post Booster Vaccination |
|---|---|
| Description | The antibody concentrations for anti-PRP were presented as geometric mean concentrations (GMCs) and expressed as µg/mL. |
| Time Frame | At Month 16 (i.e. one month after booster vaccination) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The ATP cohort for analysis of immunogenicity of the booster epoch included all evaluable subjects who complied with protocol and for whom assay results were available for antibodies against at least one study vaccine antigen component one month after the booster dose. |
| Arm/Group Title | DTPa-IPV/Hib Group |
|---|---|
| Arm/Group Description | All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side. |
| Measure Participants | 188 |
| Geometric Mean (95% Confidence Interval) [µg/mL] |
28.72
|
| Title | Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN, Post Primary Vaccination |
|---|---|
| Description | The antibody concentrations for anti-PT, anti-FHA and anti-PRN were presented as GMCs and expressed as IU/mL. |
| Time Frame | At Month 4 (i.e. one month after 3rd dose of primary vaccination) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The According-to-protocol (ATP) cohort for analysis of immunogenicity of the primary epoch included all evaluable subjects who complied with protocol and for whom assay results were available for antibodies against at least one study vaccine antigen component one month after Dose 3. |
| Arm/Group Title | DTPa-IPV/Hib Group |
|---|---|
| Arm/Group Description | All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side. |
| Measure Participants | 176 |
| Anti-FHA antibody |
120.2
|
| Anti-PRN antibody |
166.1
|
| Anti-PT antibody |
65.0
|
| Title | Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN, Post Booster Vaccination |
|---|---|
| Description | The antibody concentrations for anti-PT, anti-FHA and anti-PRN were presented as GMCs and expressed as IU/mL. |
| Time Frame | At Month 16 (i.e. one month after booster vaccination) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The ATP cohort for analysis of immunogenicity of the booster epoch included all evaluable subjects who complied with protocol and for whom assay results were available for antibodies against at least one study vaccine antigen component one month after the booster dose. |
| Arm/Group Title | DTPa-IPV/Hib Group |
|---|---|
| Arm/Group Description | All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side. |
| Measure Participants | 188 |
| anti-FHA antibody |
268.4
|
| anti-PRN antibody |
563.4
|
| anti-PT antibody |
107.9
|
| Title | Number of Subjects With Any Solicited Local Adverse Events (AEs) Following Each Dose of Primary Vaccination |
|---|---|
| Description | The solicited local AEs assessed were pain, redness and swelling at injection site. Any = Occurrence of the AE regardless of the intensity grade. |
| Time Frame | During the 4-day (Days 0-3) follow-up period after each primary vaccination dose (i.e. at Day 0, at Month 1.5 and at Month 3) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Total vaccinated cohort (TVC) for analysis of safety of the primary epoch: all subjects with at least one primary vaccine dose administration documented. |
| Arm/Group Title | DTPa-IPV/Hib Group |
|---|---|
| Arm/Group Description | All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side. |
| Measure Participants | 232 |
| Any Pain, Dose 1 |
58
24.7%
|
| Any Redness, Dose 1 |
83
35.3%
|
| Any Swelling, Dose 1 |
45
19.1%
|
| Any Pain, Dose 2 |
47
20%
|
| Any Redness, Dose 2 |
89
37.9%
|
| Any Swelling, Dose 2 |
58
24.7%
|
| Any Pain, Dose 3 |
50
21.3%
|
| Any Redness, Dose 3 |
96
40.9%
|
| Any Swelling, Dose 3 |
63
26.8%
|
| Title | Number of Subjects With Any Solicited Local AEs Following Booster Vaccination |
|---|---|
| Description | The solicited local AEs assessed were pain, redness and swelling at injection site. Any = Occurrence of the AE regardless of the intensity grade. |
| Time Frame | During the 4-day (Days 0-3) follow-up period after booster vaccination dose (i.e. at Month 15) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Total vaccinated cohort (TVC) for analysis of safety of the booster epoch: all subjects with at least one booster vaccine dose administration documented. |
| Arm/Group Title | DTPa-IPV/Hib Group |
|---|---|
| Arm/Group Description | All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side. |
| Measure Participants | 225 |
| Any Pain |
71
30.2%
|
| Any Redness |
101
43%
|
| Any Swelling |
73
31.1%
|
| Title | Number of Subjects With Any Solicited General AEs Following Each Dose of Primary Vaccination |
|---|---|
| Description | The solicited general AEs assessed were drowsiness, irritability/fussiness, loss of appetite and fever. Any = Occurrence of the AE regardless of the intensity grade. Any fever = Fever (axillary) ≥ 37.5°C. |
| Time Frame | During the 4-day (Days 0-3) follow-up period after each primary vaccination dose (i.e. at Day 0, at Month 1.5 and at Month 3) |
Outcome Measure Data
| Analysis Population Description |
|---|
| TVC for analysis of safety of the primary epoch: all subjects with at least one primary vaccine dose administration documented. |
| Arm/Group Title | DTPa-IPV/Hib Group |
|---|---|
| Arm/Group Description | All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side. |
| Measure Participants | 232 |
| Any Drowsiness, Dose 1 |
82
34.9%
|
| Any Irritability / Fussiness, Dose 1 |
100
42.6%
|
| Any Loss Of Appetite, Dose 1 |
33
14%
|
| Any Temperature/(Axillary) (°C), Dose 1 |
14
6%
|
| Any Drowsiness, Dose 2 |
69
29.4%
|
| Any Irritability / Fussiness, Dose 2 |
104
44.3%
|
| Any Loss Of Appetite, Dose 2 |
34
14.5%
|
| Any Temperature/(Axillary) (°C), Dose 2 |
32
13.6%
|
| Any Drowsiness, Dose 3 |
65
27.7%
|
| Any Irritability / Fussiness, Dose 3 |
106
45.1%
|
| Any Loss Of Appetite, Dose 3 |
43
18.3%
|
| Any Temperature/(Axillary) (°C), Dose 3 |
28
11.9%
|
| Title | Number of Subjects With Any Solicited General AEs Following Booster Vaccination |
|---|---|
| Description | The solicited general AEs assessed were drowsiness, irritability/fussiness, loss of appetite and fever. Any = Occurrence of the AE regardless of the intensity grade. Any fever = Fever (axillary) ≥ 37.5°C. |
| Time Frame | During the 4-day (Days 0-3) follow-up period after booster vaccination dose (i.e. at Month 15) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Total vaccinated cohort (TVC) for analysis of safety of the booster epoch: all subjects with at least one booster vaccine dose administration documented. |
| Arm/Group Title | DTPa-IPV/Hib Group |
|---|---|
| Arm/Group Description | All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side. |
| Measure Participants | 225 |
| Any Drowsiness |
54
23%
|
| Any Irritability / Fussiness |
88
37.4%
|
| Any Loss Of Appetite |
40
17%
|
| Any Temperature/(Axillary) (°C) |
26
11.1%
|
| Title | Number of Subjects With Unsolicited AEs Following Each Dose of Primary Vaccination |
|---|---|
| Description | An unsolicited AE was defined as any AE reported in addition to those solicited during the clinical study and any solicited AE with onset outside the specified period of follow-up for solicited AEs. Any = Occurrence of the AE regardless of the intensity grade. |
| Time Frame | During the 31-day (Days 0-30) follow-up period after each primary vaccination dose (i.e. at Day 0, at Month 1.5 and at Month 3) |
Outcome Measure Data
| Analysis Population Description |
|---|
| TVC for analysis of safety of the primary epoch: all subjects with at least one primary vaccine dose administration documented. |
| Arm/Group Title | DTPa-IPV/Hib Group |
|---|---|
| Arm/Group Description | All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side. |
| Measure Participants | 235 |
| Count of Participants [Participants] |
48
20.4%
|
| Title | Number of Subjects With Unsolicited AEs Following Booster Vaccination |
|---|---|
| Description | An unsolicited AE was defined as any AE reported in addition to those solicited during the clinical study and any solicited AE with onset outside the specified period of follow-up for solicited AEs. Any = Occurrence of the AE regardless of the intensity grade. |
| Time Frame | During the 31-day (Days 0-30) follow-up period after booster vaccination dose (i.e. at Month 15) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Total vaccinated cohort (TVC) for analysis of safety of the booster epoch: all subjects with at least one booster vaccine dose administration documented. |
| Arm/Group Title | DTPa-IPV/Hib Group |
|---|---|
| Arm/Group Description | All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side. |
| Measure Participants | 225 |
| Count of Participants [Participants] |
13
5.5%
|
| Title | Number of Subjects With Serious Adverse Events (SAEs) |
|---|---|
| Description | The SAEs assessed included any untoward medical occurrences that resulted in death, were life threatening, required hospitalisation or prolongation of existing hospitalisation or resulted in disability/incapacity. Any = Occurrence of the AE regardless of the intensity grade. |
| Time Frame | During the entire study period (i.e. from Day 0 until Month 16) |
Outcome Measure Data
| Analysis Population Description |
|---|
| TVC for analysis of safety of the primary epoch: all subjects with at least one primary vaccine dose administration documented, and TVC for analysis of safety of the booster epoch: all subjects with the booster vaccine dose administration documented. |
| Arm/Group Title | DTPa-IPV/Hib Group |
|---|---|
| Arm/Group Description | All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side. |
| Measure Participants | 235 |
| Count of Participants [Participants] |
3
1.3%
|
Adverse Events
| Time Frame | Solicited local & general AEs: during the 4-day (Days 0-3) follow-up period after each primary & booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up period after each primary & booster vaccination. SAEs: from Day 0 until Month 16. | |
|---|---|---|
| Adverse Event Reporting Description | Solicited local and general AEs, unsolicited AEs, and SAEs were reported for the Primary Epoch and for the Booster Epoch. | |
| Arm/Group Title | DTPa-IPV/Hib Group | |
| Arm/Group Description | All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side. | |
All Cause Mortality |
||
| DTPa-IPV/Hib Group | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/235 (0%) | |
Serious Adverse Events |
||
| DTPa-IPV/Hib Group | ||
| Affected / at Risk (%) | # Events | |
| Total | 3/235 (1.3%) | |
| Congenital, familial and genetic disorders | ||
| Heart disease congenital | 1/235 (0.4%) | 1 |
| Patent ductus arteriosus | 1/235 (0.4%) | 1 |
| Gastrointestinal disorders | ||
| Anal fistula | 1/235 (0.4%) | 1 |
| Proctitis | 1/235 (0.4%) | 1 |
| Infections and infestations | ||
| Gastric infection | 1/235 (0.4%) | 1 |
| Vascular disorders | ||
| Circulatory collapse | 1/235 (0.4%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| DTPa-IPV/Hib Group | ||
| Affected / at Risk (%) | # Events | |
| Total | 201/235 (85.5%) | |
| Blood and lymphatic system disorders | ||
| Anaemia | 2/235 (0.9%) | 2 |
| Cardiac disorders | ||
| Cardiovascular disorder | 1/235 (0.4%) | 1 |
| Congenital, familial and genetic disorders | ||
| Developmental hip dysplasia | 1/235 (0.4%) | 1 |
| Gastrointestinal disorders | ||
| Constipation | 1/235 (0.4%) | 2 |
| Flatulence | 1/235 (0.4%) | 1 |
| Infantile colic | 1/235 (0.4%) | 2 |
| Regurgitation | 1/235 (0.4%) | 1 |
| Vomiting | 2/235 (0.9%) | 2 |
| Diarrhoea | 1/235 (0.4%) | 1 |
| General disorders | ||
| Injection site erythema | 140/235 (59.6%) | 369 |
| Injection site pain | 103/235 (43.8%) | 226 |
| Injection site swelling | 102/235 (43.4%) | 239 |
| Pyrexia | 67/235 (28.5%) | 104 |
| Irritability postvaccinal | 157/235 (66.8%) | 398 |
| Immune system disorders | ||
| Food allergy | 1/235 (0.4%) | 1 |
| Hypersensitivity | 2/235 (0.9%) | 2 |
| Infections and infestations | ||
| Bronchitis | 3/235 (1.3%) | 3 |
| Ear infection | 1/235 (0.4%) | 1 |
| Nasopharyngitis | 3/235 (1.3%) | 3 |
| Pharyngitis | 2/235 (0.9%) | 2 |
| Respiratory tract infection | 1/235 (0.4%) | 1 |
| Respiratory tract infection viral | 5/235 (2.1%) | 6 |
| Rhinitis | 15/235 (6.4%) | 18 |
| Tracheitis | 2/235 (0.9%) | 2 |
| Tracheobronchitis | 1/235 (0.4%) | 1 |
| Upper respiratory tract infection | 4/235 (1.7%) | 7 |
| Urinary tract infection | 1/235 (0.4%) | 1 |
| Varicella | 2/235 (0.9%) | 2 |
| Viral infection | 2/235 (0.9%) | 2 |
| Enteritis infectious | 1/235 (0.4%) | 1 |
| Metabolism and nutrition disorders | ||
| Decreased appetite | 93/235 (39.6%) | 150 |
| Iron deficiency | 1/235 (0.4%) | 1 |
| Nervous system disorders | ||
| Autonomic nervous system imbalance | 1/235 (0.4%) | 1 |
| Dystonia | 1/235 (0.4%) | 1 |
| Hydrocephalus | 2/235 (0.9%) | 2 |
| Idiopathic intracranial hypertension | 1/235 (0.4%) | 1 |
| Motor dysfunction | 1/235 (0.4%) | 1 |
| Poor quality sleep | 1/235 (0.4%) | 1 |
| Somnolence | 131/235 (55.7%) | 270 |
| Tremor | 1/235 (0.4%) | 1 |
| Psychiatric disorders | ||
| Agitation | 1/235 (0.4%) | 1 |
| Nightmare | 1/235 (0.4%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||
| Cough | 2/235 (0.9%) | 2 |
| Rhinorrhoea | 4/235 (1.7%) | 4 |
| Skin and subcutaneous tissue disorders | ||
| Dermatitis allergic | 1/235 (0.4%) | 1 |
| Dermatitis atopic | 1/235 (0.4%) | 2 |
| Rash | 5/235 (2.1%) | 5 |
| Rash papular | 1/235 (0.4%) | 1 |
| Urticaria | 1/235 (0.4%) | 1 |
| Erythema | 1/235 (0.4%) | 1 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
| Name/Title | GSK Response Center |
|---|---|
| Organization | GlaxoSmithKline |
| Phone | 866-435-7343 |
| lrs54533@gsk.com |
Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT02858440
Other Study ID Numbers:
- 116194
- 2013-005577-43
First Posted:
Aug 8, 2016
Last Update Posted:
Sep 24, 2019
Last Verified:
Sep 1, 2019