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OpenTrials
Completed

NCT Number: NCT00334334

Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' 10-valent Pneumococcal Conjugate Vaccine.

Three dose primary vaccination of healthy infants between 6 to 16 weeks of age at the time of the first vaccination against Streptococcus pneumonia, Neisseria meningitidis and Haemophilus influenzae type b.

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Key information

Conditions

Infections, Streptococcal Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Lung Diseases Pneumonia Respiratory Tract Diseases Respiratory Tract Infections Streptococcal Infections

Age range

6 week–16 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Bad Saulgau, Baden-Wurttemberg, Germany

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • male or female between, and including, 6-16 weeks (42 to 118 days) of age at the time of the first vaccination, free of obvious health problems and with written informed consent obtained from the parent/guardian of the subject.

Exclusion criteria

  • use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the entire study period.
  • Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before each dose of vaccine(s) and ending 7 days after dose 1 and dose 2 or 1 month after dose 3.
  • Previous vaccinations against diseases which are targeted by the vaccines used in the study.

Treatment and study plan

Pneumococcal (vaccine)

Biological

Primary outcomes

  1. Post at least 1 dose: rectal fever >39°C

Secondary outcomes

  1. Post each dose: solicited/unsolicited AEs (4/31 days), SAEs (whole study); post dose 2 & 3: Ab conc to vaccine antigens

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

To Assess Safety, Reactogenicity and Immunogenicity of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine, When Co-administered With DTPa-combined Vaccines and MenC or Hib-MenC Vaccines During the First 6 Months of Age.

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Jun 7, 2006
Registry last updated
Nov 4, 2016

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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