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OpenTrials
Completed

NCT Number: NCT00581035

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

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

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Key information

Conditions

Healthy Bacterial Infections Bacterial Infections and Mycoses Gram-Negative Bacterial Infections Gram-Positive Bacterial Infections Infections Meningitis Meningococcal Infections Neisseriaceae Infections Nervous System Diseases Neuroinflammatory Diseases Pneumococcal Infections Streptococcal Infections

Age range

42 day–63 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy infants aged 6 to 9 weeks

Treatment and study plan

Prevenar and Meningitec

Biological

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

Prevenar

Biological

1 dose at 2,3.5,6 and 12 months

Meningitec

Biological

1 dose at 2,6 and 12 months

Primary outcomes

  1. The pneumococcal and meningococcal responses achieved after the infant series

    Time frame: 7 months

Secondary outcomes

  1. The pneumococcal and meningococcal responses achieved after the toddler dose

    Time frame: 13 months

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Study completion
2007
First posted
Dec 27, 2007
Registry last updated
Dec 27, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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