Immunogenicity & Safety Study of Combined/Separate Vaccine(s) Against Common Diseases in Infants (2,4,6 Months of Age).

Study to Assess Immunogenicity and Reactogenicity of Three Doses of GSK Bio's Combined Hib-MenC Vaccine Co-admind With GSK Bio's DTPa-HBV-IPV Vaccine and of Two Doses of Baxters Meningococcal C Conjugate Vaccine Co-admind With GSK Bio's DTPa-HBV-IPV/Hib Vaccine

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00352963

Enrollment

480

Registered

2006-07-17

Start date

2003-09-30

Completion date

2004-07-16

Last updated

2020-01-06

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

Conditions

Acellular Pertussis, Diphtheria, Hepatitis B, Poliomyelitis, Tetanus

Keywords

Open, phase 3, Infanrix hexa™, Hib-MenC, co-administered

Brief summary

This study will evaluate the immunogenicity of the co-administration of different combinations of DTPa, IPV, hepatitis B, Hib and Men C vaccines during the first year of life.

Interventions

BIOLOGICALStudy vaccines: IH+Hib-MenC/NVC; Control: IH+Meningitec

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 7 Days

Healthy volunteers

Yes

Inclusion criteria

* Healthy male or female infant between, & including, 0 & 7 days of age at the time of the inclusion. Born after a normal gestation period (between 36 & 42 weeks). * Written informed consent obtained from the parent/guardian of the subject.

Exclusion criteria

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) or planned use during the study period. * Administration of immunosuppressants or other immune-modifying drugs from birth. * Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. * Administration / planned administration of a vaccine not foreseen by the study protocol during the period starting from birth and ending 30 days after the last dose except BCG vaccination if given before the 30-day period preceding the administration of the 1st dose of Infanrix penta™ or Infanrix hexa™ in combination with a meningococcal C vaccine. * Evidence of previous or intercurrent diphtheria, tetanus, pertussis, polio, hepatitis B, meningococcal C and Hib disease. * Evidence of previous diphtheria, tetanus, pertussis, polio, hepatitis B, meningococcal C and Hib vaccination.

Design outcomes

Primary

Measure	Time frame
At M7: Antibodies to PRP, MenC HBsAg	—

Secondary

Measure	Time frame
At M7: Abs. to all vaccine antigens	—
At M6: Abs. to PRP & MenC	—
Solicited (D0-3); unsol. events (D0-30); SAEs (full study)	—

Countries

Spain

Outcome results

None listed

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