Study to evaluate the immune response of infants to a new infant immunisation schedule which includes a new vaccine protecting against hepatitis B and a reduced dose schedule for meningococcal group C conjugate vaccine.

A phase IV study to evaluate the primary and booster immune responses of UK infants receiving a licensed 6-in-1 DTaP/IPV/Hib/HBV vaccine(Infanrix-Hexa™) with a 13-valent pneumococcal conjugate vaccine and incorporating a randomisation study of a single dose of 3 different meningococcal group C conjugate vaccines at 3 months of age. - Hepatitis B vaccination in infants (version 1.1)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-003026-25-GB

Enrollment

300

Registered

2012-08-21

Start date

2012-09-28

Completion date

Unknown

Last updated

2019-04-30

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

Conditions

Not applicable

Interventions

Trade Name: Infanrix Hexa Product Name: Infanrix Hexa Pharmaceutical Form: Powder and solvent for solution for injection in pre-filled syringe INN or Pr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male or female infants born at term (at least 37 weeks gestation) who aged =65 years) no F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: Participant may not be included in the study if any of the following apply: 1. History of infection with Haemophilus influenzae serotype b (Hib), pneumococcal or meningococcal disease, pertussis, polio, diphtheria, tetanus or hepatitis B 2. History of maternal acute or chronic hepatitis B infection 3. Confirmed or suspected immunosuppressive or immunodeficient condition (including HIV) 4. Bleeding disorders and/or prolonged bleeding time 5. Major congenital defects or chronic disease 6. Premature birth (<37 weeks gestation at birth) 7. Previously received any vaccine(particularly hepatitis B)

Design outcomes

Primary

Measure	Time frame
Main Objective: This study will assess the immune responses of infants receiving a licensed 6-in-1 vaccine (Infanrix-Hexa™) instead of the current 5-in-1 vaccine (Pediacel™) when given at the UK schedule of 2-3-4 months when given with one of three licensed meningococcal group C (MenC) vaccines at 3 months and the pneumococcal vaccine at 2 and 4 months of age. The study will primarily ensure that this new schedule protects infants against Haemophilus influenzae group B (Hib) and Meningococcal group C (MenC) disease as responses to these components of the vaccine have been shown in the past to be susceptible to changes in vaccine type and dosing schedule. ; Secondary Objective: The study will assess the immune responses of infants to other components of the immunisation schedule including diphtheria, tetanus and the 13 pneumococcal serotypes and hepatitis B. The study will also assess the safety and tolerability of Infanrix-Hexa™ using a standardised 7-day diary following each vaccination visit. ; Primary end point(s): Based on internationally-accepted correlates of protection, the primary outcome measures are: 1. The amount of antibody produced against Haemophilus influenzae serotype B (Hib) and the proportion of infants attaining protective antibody levels (= 0.15µg/ml and 1.00µg/ml) after primary and booster immunisation 2. The amount of antibody produced against meningococcal serogroup C and the proportion of infants attaining protective antibody levels (serum bactericidal antibody titres = 8 and 128) after primary and booster immunisation ;Timepoint(s) of evaluation of this end point: The evaluation will commence once the final blood sample from the last child in the study has been processed.	—

Measure

Time frame

Main Objective: This study will assess the immune responses of infants receiving a licensed 6-in-1 vaccine (Infanrix-Hexa™) instead of the current 5-in-1 vaccine (Pediacel™) when given at the UK schedule of 2-3-4 months when given with one of three licensed meningococcal group C (MenC) vaccines at 3 months and the pneumococcal vaccine at 2 and 4 months of age. The study will primarily ensure that this new schedule protects infants against Haemophilus influenzae group B (Hib) and Meningococcal group C (MenC) disease as responses to these components of the vaccine have been shown in the past to be susceptible to changes in vaccine type and dosing schedule. ; Secondary Objective: The study will assess the immune responses of infants to other components of the immunisation schedule including diphtheria, tetanus and the 13 pneumococcal serotypes and hepatitis B. The study will also assess the safety and tolerability of Infanrix-Hexa™ using a standardised 7-day diary following each vaccination visit. ; Primary end point(s): Based on internationally-accepted correlates of protection, the primary outcome measures are: 1. The amount of antibody produced against Haemophilus influenzae serotype B (Hib) and the proportion of infants attaining protective antibody levels (= 0.15µg/ml and 1.00µg/ml) after primary and booster immunisation 2. The amount of antibody produced against meningococcal serogroup C and the proportion of infants attaining protective antibody levels (serum bactericidal antibody titres = 8 and 128) after primary and booster immunisation ;Timepoint(s) of evaluation of this end point: The evaluation will commence once the final blood sample from the last child in the study has been processed.

—

Secondary

Measure	Time frame
Secondary end point(s): The amount of antibody produced against the 13 pneumococcal serotypes, diphtheria, tetanus and hepatitis B;Timepoint(s) of evaluation of this end point: The evaluation will commence once the final blood sample from the last child in the study has been processed.	—

Countries

United Kingdom

Contacts

Public ContactProfessor Elizabeth Miller

Health Protection Agency Colindale, Immunisation, Blood Safety and Hepatitis Department

liz.miller@hpa.org.uk02082004400

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026