Phase II, double blind, randomised, controlled study to evaluate immunogenicity, reactogenicity and safety of GlaxoSmithKline Biologicals Hib-menAC vaccine (Ghana)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN35754083

Enrollment

280

Registered

2004-09-22

Start date

2005-01-19

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Vaccination against meningococcal disease Infections and Infestations Vaccination

Interventions

Intramuscular administration of the vaccines at 6, 10 and 14 weeks of age: Group 1: GlaxoSmithKline (GSK) Biologicals' Haemophilus influenzae type b (Hib)-meningitis AC (menAC) extemporaneously mixed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Healthy infants between 6 - 8 weeks of age at first vaccination.

Exclusion criteria

Exclusion criteria: Any condition that may affect the health of the subject, or the interpretation of the results.

Design outcomes

Primary

Measure	Time frame
1. Demonstrate immunogenicity of HibMenAMenC/DPTwHepB with respect to serum bacterial assay(SBA)-Men A and SBA-MenC 2. Demonstrate that HibMenAMenC/DPTwHepB is non-inferior to the control vaccine DPTwHepB/Hib with respect to immunogenicity of all common antigens (anti-PRP, anti-Diphtheria, anti-tetanus, anti-BP, anti-HBs)	—

Secondary

Measure	Time frame
1. Evaluate antibody persistence induced by the primary vaccination with HibMenAMenC/DPTwHepB versus DPTwHepB/Hib with respect to immunogenicity of all antigens administered at 12 months of age 2. Evaluate immune memory induced by primary vaccination with HibMenAMenC/DPTwHepB by administering 10 micrograms of each meningococcal A and C polysaccharide (1/5 of a dose of Mencevax AC) using unprimed subjects of DPTwHepB/Hib as control 3. Assess immunogenecity and safety of the primary vaccination after each vaccine dose and overall in the two study groups 4. To assess the reactogenicity and safety of the 10 micrograms of meningococcal A and C polysaccharide (1/5 of a dose of Mencevax AC) in subjects primed with either HibMenAMenC/DPTwHepB or DPTwHepB/Hib	—

Measure

Time frame

1. Evaluate antibody persistence induced by the primary vaccination with HibMenAMenC/DPTwHepB versus DPTwHepB/Hib with respect to immunogenicity of all antigens administered at 12 months of age 2. Evaluate immune memory induced by primary vaccination with HibMenAMenC/DPTwHepB by administering 10 micrograms of each meningococcal A and C polysaccharide (1/5 of a dose of Mencevax AC) using unprimed subjects of DPTwHepB/Hib as control 3. Assess immunogenecity and safety of the primary vaccination after each vaccine dose and overall in the two study groups 4. To assess the reactogenicity and safety of the 10 micrograms of meningococcal A and C polysaccharide (1/5 of a dose of Mencevax AC) in subjects primed with either HibMenAMenC/DPTwHepB or DPTwHepB/Hib

—

Countries

Ghana

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 5, 2026