Immunogenicity and Reactogenicity of DTPa-HBV-IPV/Hib Vaccine Followed by the Same Vaccine and Oral Polio Vaccine

Study to Assess the Immunogenicity and Reactogenicity of DTPa-HBV-IPV Mixed With Hib Vaccine in Healthy Infants, Followed by a Dose of the Same Vaccine Administered Simultaneously With One Dose of Oral Polio Vaccine (OPV)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01457560

Enrollment

Registered

2011-10-24

Start date

2000-02-29

Completion date

2001-04-30

Last updated

2016-08-05

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

Conditions

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

Keywords

Oral polio vaccine (OPV), DTPa-HBV-IPV/Hib vaccine

Brief summary

This study will assess the immunogenicity and safety of the GlaxoSmithKline (GSK) Biologicals' (formerly SmithKline Beecham Biologicals') combined DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine administered in the 3rd, 5th, 11th month of life. The last dose of DTPa-HBV-IPV/Hib will be given simultaneously with one dose of OPV vaccine.

Interventions

BIOLOGICALDTPa-HBV-IPV/Hib (Infanrix hexa™)

Three doses administered intramuscularly

BIOLOGICALOPV

One dose administered orally

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Weeks to 16 Weeks

Healthy volunteers

Yes

Inclusion criteria

The inclusion criteria will be checked at study entry. If any of these criteria does not apply, the subject is not eligible for inclusion in the study. * Healthy male and female subjects in the ≥12 and \<16 weeks of life at the time of the first vaccination. * Free of obvious health problems as established by medical history and clinical examination before entering into the study. * Written informed consent obtained from the parents/guardians of the infant after they have been advised of the risks and benefits of the study in a language which they clearly understood, and before performance of any study procedure.

Exclusion criteria

The

Design outcomes

Primary

Measure	Time frame
Immunogenicity with respect to the components of the study vaccine in terms of number of subjects with antibody titres greater than or equal to cut off values	One month after the second dose and one month after the third dose of the primary vaccination course ( Month 3 and Month 9)

Secondary

Measure	Time frame
Immunogenicity with respect to the components of the study vaccine in terms of antibody titers	Before the first dose (Month 0), one month after the second dose and one month after the third dose of the primary vaccination course ( Month 3 and Month 9).
Immunogenicity with respect to the components of the study vaccine in terms of number of subjects with vaccine response	One month after the second dose, and one month after the third dose of the primary vaccination course (Month 3 and Month 9).
Immunogenicity with respect to the components of the study vaccine in terms of number of subjects with antibody titres greater than or equal to cut off values	Before the first dose ( Month 0 )
Number of subjects with solicited and unsolicited adverse events	After each dose of the study vaccines (Month 0, Month 3 and Month 9) and overall
Number of subjects with serious adverse events	During the study period (Month 0 to Month 9)
Immunogenicity with respect to the components of the study vaccine in terms of antibody titres greater than or equal to cut off values	One month after the second dose, and one month after the third dose of the primary vaccination course (Month 3 and Month 9).

Outcome results

None listed

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