Safety Study of GSK Biologicals' DTPa-IPV/Hib (Infanrix™-IPV/Hib)

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00964028
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Duration (Months): 4.3
• Patients Per Site Per Month: 11.5

Study Details

Study Description

Brief Summary

This study will evaluate the safety and reactogenicity of Infanrix-IPV/Hib given as a three-dose primary vaccination course to healthy infants at 2-3-4 or 3-4-5 months of age.

Condition or Disease	Intervention/Treatment	Phase
Haemophilus Influenzae Type b; Acellular Pertussis; Diphtheria; Tetanus; Poliomyelitis	Biological: Infanrix™-IPV/Hib	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Safety and Reactogenicity of GSK Biologicals' DTPa-IPV/Hib (Infanrix™-IPV/Hib) in Infants
• Study Start Date: Dec 1, 2009
• Actual Primary Completion Date: Apr 12, 2010
• Actual Study Completion Date: Apr 12, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: INFANRIX-IPV/HIB M2-M3-M4 GROUP Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age (M2-M3-M4), administered intramuscularly into the upper right side of the thigh.	Biological: Infanrix™-IPV/Hib; Intramuscular, three doses
Experimental: INFANRIX-IPV/HIB M3-M4-M5 GROUP Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age (M3-M4-M5), administered intramuscularly into the upper right side of the thigh.	Biological: Infanrix™-IPV/Hib; Intramuscular, three doses

Outcome Measures

Primary Outcome Measures

1. Number of Subjects With Any Solicited Local Symptoms [During the 4-day (Days 0-3) follow-up period after each dose and across doses]

   Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.

2. Number of Subjects With Any Solicited General Symptoms [During the 4-day (Days 0-3) follow-up period after each dose and across doses]

   Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as axillary temperature equal to or above 37.0 degrees Celsius (°C)]. Any = occurrence of any general symptom regardless of intensity grade or relationship to vaccination.

3. Number of Subjects With Unsolicited Adverse Events (AEs) [During the 31-day (Days 0-30) follow-up period after each vaccination]

   An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

4. Number of Subjects With Serious Adverse Events (SAEs) [During the whole study period (from Day 0 until Month 3 or Month 4)]

   Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Days to 90 Days
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• A male or female infant between, and including, 60 and 90 days of age at the time of the first study visit.

• Born after a gestation period of 36 to 42 weeks inclusive.

• Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.

• Written informed consent obtained from the parent or guardian of the subject.

• Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

• Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.

• Chronic administration of immunosuppressants or other immune-modifying drugs since birth.

• Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.

• Administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during the study period, with the exception of hepatitis B vaccine.

• 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 product.

• Evidence of previous or intercurrent diphtheria, tetanus, pertussis, poliomyelitis and/or Hib disease.

• Previous vaccination against diphtheria, tetanus, pertussis, poliovirus and/or Haemophilus influenzae type b diseases.

• History of seizures or progressive neurological disease.

• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.

• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.

• Major congenital defects or serious chronic illness.

The following condition is temporary or self-limiting and a subject may be vaccinated once the condition has resolved and no other exclusion criteria are met:

• Current febrile illness or axillary temperature > 37.0 ºC or other moderate to severe illness within 24 hours of study vaccine administration.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Wuzhou	Guangxi	China	543100

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT00964028
• Other Study ID Numbers: 112065
• First Posted: Aug 24, 2009
• Last Update Posted: Jun 6, 2018
• Last Verified: Apr 1, 2017

• Keywords provided by GlaxoSmithKline: Combined vaccine
• Additional relevant MeSH terms: Diphtheria; Poliomyelitis

Study Results

Participant Flow

Pre-assignment Detail	During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.

Arm/Group Title	Infanrix-IPV/Hib M2-M3-M4 Group	Infanrix-IPV/Hib M3-M4-M5 Group
Arm/Group Description	Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib vaccine at 2, 3 and 4 months of age (M2-M3-M4), administered intramuscularly into the upper right side of the thigh.	Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib vaccine at 3, 4 and 5 months of age (M3-M4-M5), administered intramuscularly into the upper right side of the thigh.
Period Title: Overall Study
STARTED	25	25
COMPLETED	25	24
NOT COMPLETED	0	1

Baseline Characteristics

Arm/Group Title	Infanrix-IPV/Hib M2-M3-M4 Group	Infanrix-IPV/Hib M3-M4-M5 Group	Total
Arm/Group Description	Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib vaccine at 2, 3 and 4 months of age (M2-M3-M4), administered intramuscularly into the upper right side of the thigh.	Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib vaccine at 3, 4 and 5 months of age (M3-M4-M5), administered intramuscularly into the upper right side of the thigh.	Total of all reporting groups
Overall Participants	25	25	50
Age (Weeks) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Weeks]	10.1 (1.36)	14.2 (1.18)	12.15 (2.42)
Sex: Female, Male (Count of Participants)
Female	7 28%	11 44%	18 36%
Male	18 72%	14 56%	32 64%
Race/Ethnicity, Customized (Count of Participants)
Asian-East Asian heritage	24 96%	25 100%	49 98%
Asian-Japanese heritage	1 4%	0 0%	1 2%

Outcome Measures

1. Primary Outcome

Title	Number of Subjects With Any Solicited Local Symptoms
Description	Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.
Time Frame	During the 4-day (Days 0-3) follow-up period after each dose and across doses

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.

Arm/Group Title	Infanrix-IPV/Hib M2-M3-M4 Group	Infanrix-IPV/Hib M3-M4-M5 Group
Arm/Group Description	Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib vaccine at 2, 3 and 4 months of age (M2-M3-M4), administered intramuscularly into the upper right side of the thigh.	Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib vaccine at 3, 4 and 5 months of age (M3-M4-M5), administered intramuscularly into the upper right side of the thigh.
Measure Participants	25	25
Any Pain, Dose 1	4 16%	2 8%
Any Redness, Dose 1	2 8%	0 0%
Any Swelling, Dose 1	1 4%	0 0%
Any Pain, Dose 2	1 4%	1 4%
Any Redness, Dose 2	2 8%	0 0%
Any Swelling, Dose 2	1 4%	0 0%
Any Pain, Dose 3	2 8%	1 4%
Any Redness, Dose 3	2 8%	0 0%
Any Swelling, Dose 3	0 0%	0 0%
Any Pain, Across doses	4 16%	3 12%
Any Redness, Across doses	4 16%	0 0%
Any Swelling, Across doses	2 8%	0 0%

2. Primary Outcome

Title	Number of Subjects With Any Solicited General Symptoms
Description	Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as axillary temperature equal to or above 37.0 degrees Celsius (°C)]. Any = occurrence of any general symptom regardless of intensity grade or relationship to vaccination.
Time Frame	During the 4-day (Days 0-3) follow-up period after each dose and across doses

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.

Arm/Group Title	Infanrix-IPV/Hib M2-M3-M4 Group	Infanrix-IPV/Hib M3-M4-M5 Group
Arm/Group Description	Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib vaccine at 2, 3 and 4 months of age (M2-M3-M4), administered intramuscularly into the upper right side of the thigh.	Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib vaccine at 3, 4 and 5 months of age (M3-M4-M5), administered intramuscularly into the upper right side of the thigh.
Measure Participants	25	25
Any Drowsiness, Dose 1	9 36%	1 4%
Any Irritability, Dose 1	9 36%	5 20%
Any Loss of appetite, Dose 1	7 28%	1 4%
Any Fever, Dose 1	8 32%	8 32%
Any Drowsiness, Dose 2	3 12%	5 20%
Any Irritability, Dose 2	6 24%	3 12%
Any Loss of appetite, Dose 2	3 12%	3 12%
Any Fever, Dose 2	5 20%	5 20%
Any Drowsiness, Dose 3	2 8%	0 0%
Any Irritability, Dose 3	5 20%	4 16%
Any Loss of appetite, Dose 3	3 12%	1 4%
Any Fever, Dose 3	7 28%	3 12%
Any Drowsiness, Across doses	12 48%	5 20%
Any Irritability, Across doses	15 60%	8 32%
Any Loss of appetite, Across doses	9 36%	4 16%
Any Fever, Across doses	13 52%	12 48%

3. Primary Outcome

Title	Number of Subjects With Unsolicited Adverse Events (AEs)
Description	An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Time Frame	During the 31-day (Days 0-30) follow-up period after each vaccination

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.

Arm/Group Title	Infanrix-IPV/Hib M2-M3-M4 Group	Infanrix-IPV/Hib M3-M4-M5 Group
Arm/Group Description	Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib vaccine at 2, 3 and 4 months of age (M2-M3-M4), administered intramuscularly into the upper right side of the thigh.	Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib vaccine at 3, 4 and 5 months of age (M3-M4-M5), administered intramuscularly into the upper right side of the thigh.
Measure Participants	25	25
Count of Participants [Participants]	16 64%	1 4%

4. Primary Outcome

Title	Number of Subjects With Serious Adverse Events (SAEs)
Description	Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time Frame	During the whole study period (from Day 0 until Month 3 or Month 4)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.

Arm/Group Title	Infanrix-IPV/Hib M2-M3-M4 Group	Infanrix-IPV/Hib M3-M4-M5 Group
Arm/Group Description	Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib vaccine at 2, 3 and 4 months of age (M2-M3-M4), administered intramuscularly into the upper right side of the thigh.	Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib vaccine at 3, 4 and 5 months of age (M3-M4-M5), administered intramuscularly into the upper right side of the thigh.
Measure Participants	25	25
Count of Participants [Participants]	0 0%	0 0%

Adverse Events

Time Frame	Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 until Month 3/4).
Arm/Group Title	Infanrix-IPV/Hib M2-M3-M4 Group		Infanrix-IPV/Hib M3-M4-M5 Group
Arm/Group Description	Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib vaccine at 2, 3 and 4 months of age (M2-M3-M4), administered intramuscularly into the upper right side of the thigh.		Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib vaccine at 3, 4 and 5 months of age (M3-M4-M5), administered intramuscularly into the upper right side of the thigh.
All Cause Mortality
	Infanrix-IPV/Hib M2-M3-M4 Group		Infanrix-IPV/Hib M3-M4-M5 Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/25 (0%)
Serious Adverse Events
	Infanrix-IPV/Hib M2-M3-M4 Group		Infanrix-IPV/Hib M3-M4-M5 Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/25 (0%)
Other (Not Including Serious) Adverse Events
	Infanrix-IPV/Hib M2-M3-M4 Group		Infanrix-IPV/Hib M3-M4-M5 Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	23/25 (92%)		16/25 (64%)
Gastrointestinal disorders
Diarrhoea	4/25 (16%)		0/25 (0%)
General disorders
Pyrexia	5/25 (20%)		0/25 (0%)
Pain	4/25 (16%)		3/25 (12%)
Redness	4/25 (16%)		0/25 (0%)
Swelling	2/25 (8%)		0/25 (0%)
Drowsiness	12/25 (48%)		5/25 (20%)
Irritability	15/25 (60%)		8/25 (32%)
Loss of appetite	9/25 (36%)		4/25 (16%)
Fever	13/25 (52%)		12/25 (48%)
Infections and infestations
Upper respiratory tract infection	10/25 (40%)		1/25 (4%)
Nasopharyngitis	4/25 (16%)		0/25 (0%)

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.