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Completed

NCT Number: NCT00307554

A Lot-to-lot Consistency (3 Lots of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine) & Non-inferiority Study

Evaluate lot-to-lot consistency, safety and reactogenicity of 3 doses of GSK Biologicals' 10-valent pneumococcal conjugate vaccine and non-inferiority with respect to Prevenar.

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Key information

Conditions

Infections, Streptococcal Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Streptococcal Infections

Age range

6 week–12 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Espoo, Finland

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About this study

Test groups: 4 (400 subjects/group). 3 groups receiving 10-valent pneumococcal conjugate vaccine (3 different lots) as follows: - 10-valent vaccine (lot 1, 2 or 3) + DTPa combined vaccine; Control group receiving Prevenar + DTPa combined vaccine

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 and 12 weeks (42-90 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 preceeding the first dose of study vaccine, or planned use during the study period.
  • Planned administration/ administration of a licensed vaccine not foreseen by the study protocol during the period starting from one month before the first dose of vaccine(s) and during the entire study period.

Treatment and study plan

Pneumococcal (vaccine)

Biological

Primary outcomes

  1. Lot-to-lot consistency: antibody (Ab) concentrations to pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F and to carrier protein PD

  2. Non-inferiority of 10-valent pneumococcal conjugate vaccine (pooled data of 3 10-Pn-PD-DiT vaccine groups) w.r.t. Prevenar: all anti-pneumococcal serotypes Ab concentrations>=0.20 µg/mL

Secondary outcomes

  1. After each vaccination, occurrence of: solicited local, general symptoms within 4 days;

    Time frame: After each vaccination

  2. Unsolicited adverse events within 31 days, SAEs (whole study period)

  3. 1m post dose3: For all vaccine pneumococcal serotypes: Opsono titres

  4. Antibody (Ab) concentrations >= 0.20 µg/mL

  5. Ab concentrations to protein D and seropositivity (S+) status

  6. S+/seroprotection status to antigens in DTPa combo vaccine

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Assess Lot-to-lot Consistency of 3 Lots (Double Blind Design) of GlaxoSmithKline Biologicals' 10-valent Pneumococcal Vaccine and Evaluate Non-inferiority to Prevenar™ (Single Blind Design) When Administered as 3-dose Primary Immunization Course Before 6 Months of Age

Important dates

Study start
2005
Study completion
2006
First posted
Mar 28, 2006
Registry last updated
Sep 26, 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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