Assess if Immune Response of GSK Biologicals' Tritanrix™-HepB/Hib-MenAC Given Without or With Hepatitis B Vaccine at Birth is at Least as Good as Tritanrix™-HepB/Hiberix™ Without Hepatitis B Vaccine at Birth, When Given to Healthy Infants

Study to Show Non-inferiority of Tritanrix™-HepB/Hib-MenAC (+/- Hepatitis B Vaccine at Birth) Versus Tritanrix™-HepB/Hiberix™ Without Hepatitis B Vacc. at Birth for Antibody Response to All Vaccine Antigens Given in Healthy Infants

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00290303

Enrollment

996

Registered

2006-02-13

Start date

2004-05-31

Completion date

2005-03-31

Last updated

2016-09-16

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

Conditions

Diphtheria, Haemophilus Influenzae Type b, Hepatitis B, Tetanus, Whole Cell Pertussis

Brief summary

The purpose of this study is to compare the immune response, safety and reactogenicity of Tritanrix™-HepB/Hib-MenAC vaccine given either with or without a birth dose of hepatitis B vaccine to Tritanrix™-HepB/Hiberix™ when given to healthy infants (born to mothers who do not carry hepatitis B virus) at 6, 10 & 14 weeks of age. This study will also include a small group of infants born to mothers who do carry hepatitis B virus; these infants will receive a birth dose of hepatitis B vaccine and will be vaccinated with Tritanrix™ HepB/Hib-MenAC at 6, 10 & 14 weeks age.

Detailed description

Randomized study with three groups (subjects born to mothers who do not carry hepatitis B virus) to receive one of the following vaccination regimens: - GSK Biologicals' Tritanrix™-HepB/Hib-MenAC and hepatitis B vaccine at birth \- GSK Biologicals' Tritanrix™-HepB/Hib-MenAC and no hepatitis B vaccine at birth - GSK Biologicals' Tritanrix™-HepB/Hiberix™ There will also be a fourth group (subjects born to mothers who do carry hepatitis B virus) to receive: - GSK Biologicals' Tritanrix™-HepB/Hib-MenAC and hepatitis B vaccine at birth

Interventions

BIOLOGICALDTPw-HBV/Hib-MenAC conjugate vaccine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

3 Days to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Healthy infants aged 3 days or less, written informed consent obtained from the parents, born after a gestation period of 36 to 42 weeks. * Result of the maternal blood sample (presence/not of hepatitis B virus) is available.

Exclusion criteria

* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * A family history of congenital or hereditary immunodeficiency. * Major congenital defects or serious chronic illness. * History of any neurologic disorders or seizures. * Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period (except for immunoglobulins given at birth to infants born to HBsAg seropositive mothers). * Acute disease at the time of enrolment. * Known exposure to diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b and/or meningococcal disease. * Hepatitis B vaccine given at birth outside the study.

Design outcomes

Primary

Measure	Time frame
Immunogenicity: One month post-dose 3, measurement of serum bactericidal titers against meningococcal serogroups A & C (SBA-MenA; SBA-MenC), anti-PRP, anti-HBs & anti-diphtheria concentrations; & in some subjects anti-tetanus & anti-BPT concentrations.	—

Secondary

Measure	Time frame
Reactogenicity and safety: After each vaccination, solicited (day 0-3, local & general) & unsolicited (day 0-30) symptoms. Over the full course of the study: serious adverse events (SAEs)	—

Countries

Philippines

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026