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Completed

NCT Number: NCT00757770

Assessment of Clinical Consistency of Three Production Lots of GSK Biologicals' HRV Vaccine

The purpose of this study is to evaluate the lot-to-lot consistency of three production lots of GSK Biologicals' HRV vaccine in terms of immunogenicity and safety in healthy infants aged 2 months at the time of first vaccination.

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Key information

Conditions

Infections, Rotavirus Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Infections RNA Virus Infections Reoviridae Infections Rotavirus Infections Virus Diseases

Age range

6 week–12 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Cali Colombia, Colombia

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
  • A male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination.
  • Written informed consent obtained from the parent or guardian of the subject.
  • Free of obvious health problems as established by medical history and clinical examination before entering into the study.

Exclusion criteria

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Child is unlikely to remain in the study area for the duration of the study.
  • Previous confirmed occurrence of rotavirus gastroenteritis.
  • Gastroenteritis within 7 days preceding the study vaccine administration.
  • Household contact with an immunosuppressed individual or pregnant woman.
  • Use of antibiotics during the period starting from 7 days before dose 1 of vaccine(s).
  • Planned administration of a vaccine (other than routine pediatric vaccines) not foreseen by the study protocol during the period starting from 14 days before each dose of study vaccine(s) and ending 14 days after.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
  • Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract or other serious medical condition as determined by the investigator.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • Major congenital defects or serious chronic illness.
  • Acute disease at time of enrollment.
  • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.

Treatment and study plan

Rotarix

Biological

Two oral doses.

Placebo

Biological

Two oral doses; The placebo consist of all components of the study vaccine i.e. excipients and buffer, but no RV particles.

Primary outcomes

  1. Serum anti-rotavirus Immunoglobulin A (IgA) antibody concentration expressed as Geometric Mean Concentrations (GMCs).

    Time frame: Two months after Dose 2.

Secondary outcomes

  1. Serum anti-rotavirus IgA antibody concentration expressed as GMCs in a subset of subjects.

    Time frame: Two months after Dose 1.

  2. Seroconversion rates to anti-rotavirus IgA antibody

    Time frame: Two months after Dose 1 (in a subset of subjects) and Dose 2 (all subjects).

  3. Vaccine take rates in a subset of subjects.

    Time frame: Two months after each dose

  4. Presence of rotavirus in stool samples in a subset of subjects

    Time frame: On the day of each vaccination and on planned days following each vaccination.

  5. For each type of solicited symptom, occurrence of the symptom

    Time frame: During the 8-day follow-up period after each vaccine dose

  6. Occurrence of unsolicited symptoms

    Time frame: During the 31-day follow-up period after each vaccine dose.

  7. Occurrence of serious adverse events

    Time frame: Throughout the study period.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Study to Assess the Clinical Consistency of Three Production Lots of GSK Biologicals' HRV Vaccine in Terms of Immunogenicity and Safety When Given to Healthy Infants at 2 and 4 Months of Age

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Sep 23, 2008
Registry last updated
Sep 7, 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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