Immunogenicity and Safety of GSK Biologicals' Infanrix Hexa in Infants

Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Infanrix Hexa Vaccine in Healthy Infants

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00753649

Enrollment

224

Registered

2008-09-16

Start date

2008-09-23

Completion date

2013-03-12

Last updated

2019-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B, Tetanus, Poliomyelitis, Diphtheria, Haemophilus Influenzae Type b, Acellular Pertussis

Keywords

Infant, First nation, Aboriginal, Canada

Brief summary

This study will evaluate GSK Biologicals' DTPa-HBV-IPV/Hib vaccine given as a three-dose primary vaccination course at 2, 4 and 6 months of age, in terms of safety and immunogenicity in different population of infants residing in Canada.

Detailed description

This protocol posting has been updated following Protocol amendment 1 (19-MAY-2010).

Interventions

BIOLOGICALInfanrix™ hexa

Intramuscular, three doses

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Weeks to 12 Weeks

Healthy volunteers

Yes

Inclusion criteria

* Subjects who the investigator believes that their parent/guardian can and will comply with the requirements of the protocol should be enrolled in the study. * A male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination. * Born after a gestation period of 36 to 42 weeks inclusive. * Healthy subjects as established by medical history before entering into the study. * Written informed consent obtained from the parent or guardian of the subject.

Exclusion criteria

* Use of any investigational or non-registered product 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 from birth until first primary vaccination dose.. * Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. * 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. * Major congenital defects or serious chronic illness. * Evidence of previous or intercurrent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and/or Hib vaccination or disease. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccines. * The following condition is temporary or self limiting and a subject may be vaccinated once the condition has resolved and no other

Design outcomes

Primary

Measure	Time frame	Description
Number of Seroprotected Subjects Against Polyribosyl-ribitol Phosphate (Anti-PRP)	One month after (POST) Dose 3.	A seroprotected subject was a subject whose anti-PRP antibody concentration was greater or equal to (≥) 0.15 microgram per milliliter (µg/mL).

Secondary

Measure	Time frame	Description
Anti-PRP Antibody Concentrations	One month after (POST) Dose 3.	Anti-PRP antibody concentrations were presented as Geometric mean Concentrations (GMC), expressed as micrograms per milliliter (μg/mL).
Number of Seroprotected Subjects Against Hepatitis B (Anti-HBs)	One month after (POST) Dose 3.	A seroprotected subject was a subject with anti-HBs antibody concentrations ≥ 10 milli-International Units ler milliliter (mIU/mL). A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete retesting/reanalysis. Some of the available blood samples initially tested with ELISA were re-tested using the new assay, CLIA.
Number of Subjects With Anti-HBs Antibody Concentrations ≥100 mIU/mL	One month after (POST) Dose 3.	The testing was done using the Enzyme-Linked Immunosorbent assay (ELISA) assay.
Number of Subjects With Anti-PRP Antibody Concentrations ≥1µg/mL	One month after (POST) Dose 3.	For this assay, 1 μg/mL was considered as the seropositivity cut-off.
Number of Subjects With Unsolicited Adverse Events (AEs)	During the 31 day (Days 0-30) post 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.
Number of Subjects With Serious Adverse Events (SAEs)	During the entire study period up to Last subject last visit on 03/12/2013	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.
Anti-HBs Antibody Concentrations	One month after (POST) Dose 3.	Anti-HBs antibody concentrations were assessed by Enzyme-Linked Immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs).

Countries

Canada

Participant flow

Recruitment details

Study started on 23-Sep-2008 and enrolled 224 subjects from Canada.

Pre-assignment details

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

Participants by arm

Arm	Count
Infanrix Hexa Aboriginal Group Subjects of aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.	112
Infanrix Hexa Non-Aboriginal Group Subjects of non-aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.	112
Total	224

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Lost to follow-up-complete vaccination	1
Overall Study	Lost to follow-up-incomplete vaccination	3
Overall Study	Migrated/moved from study area	1
Overall Study	Protocol Violation	2

Baseline characteristics

Characteristic	Infanrix Hexa Aboriginal Group	Infanrix Hexa Non-Aboriginal Group	Total
Age, Continuous	9.3 Weeks STANDARD_DEVIATION 1.38	9.2 Weeks STANDARD_DEVIATION 1.3	9.25 Weeks STANDARD_DEVIATION 1.34
Sex: Female, Male Female	62 Participants	52 Participants	114 Participants
Sex: Female, Male Male	50 Participants	60 Participants	110 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	6 / 112	0 / 112
serious Total, serious adverse events	6 / 112	0 / 112

Outcome results

Primary

Number of Seroprotected Subjects Against Polyribosyl-ribitol Phosphate (Anti-PRP)

A seroprotected subject was a subject whose anti-PRP antibody concentration was greater or equal to (≥) 0.15 microgram per milliliter (µg/mL).