Study Evaluating the Safety and Ability to Produce Immune Response of Prevenar and Meningitec Given at the Same Time

A Randomised Open Label Phase 4 Study to Evaluate the Safety and Immunogenicity of Concomitant Prevenar and Meningitec Compared to Prevenar Alone and Meningitec Alone When Used as Part of the Routine Vaccination Series in Healthy Infants

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00581035

Enrollment

712

Registered

2007-12-27

Start date

2006-01-31

Completion date

2007-05-31

Last updated

2007-12-27

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

Conditions

Healthy

Keywords

Meningococcal disease, pneumococcal disease, meningitis

Brief summary

The purpose of this study is to evaluate the safety and immunogenicity of concomitant Prevenar and Meningitec compared to Prevenar alone and Meningitec alone when used as part of the routine vaccination series in healthy infants

Interventions

BIOLOGICALPrevenar and Meningitec

1 dose of Prevenar at 2,3.5,6 and 12 months and 1 dose of Meningitec at 2,6 and 12 months

BIOLOGICALPrevenar

1 dose at 2,3.5,6 and 12 months

BIOLOGICALMeningitec

1 dose at 2,6 and 12 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

42 Days to 63 Days

Healthy volunteers

Yes

Inclusion criteria

* Healthy infants aged 6 to 9 weeks

Design outcomes

Primary

Measure	Time frame
The pneumococcal and meningococcal responses achieved after the infant series	7 months

Secondary

Measure	Time frame
The pneumococcal and meningococcal responses achieved after the toddler dose	13 months

Outcome results

None listed

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