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

Infections, Rotavirus Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00757770
• Other study ID #: 444563/033
• Status: Completed
• Phase: Phase 3
• First received: September 22, 2008
• Last updated: September 6, 2016
• Start date: August 2003
• Est. completion date: January 2004

Study information

• Verified date: September 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 854
• Est. completion date: January 2004
• Est. primary completion date: January 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Weeks to 12 Weeks

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Infections, Rotavirus
• Rotavirus Infections

Intervention

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

Locations

Country	Name	City	State
Colombia	GSK Investigational Site	Cali Colombia
Mexico	GSK Investigational Site	Mexico, D.F.
Peru	GSK Investigational Site	Lima
Spain	GSK Investigational Site	Unknown

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Colombia,  Mexico,  Peru,  Spain, 

References & Publications (1)

Lopez P, Herrera JFG, Cervantes Y, et al. Three consecutive production lots of the human monovalent RIX4414 G1P(8) rotavirus vaccine, Rotarix™ induce a consistent immune response in Latin American infants. Proc 4th World Congress Pediatr Infect Dis, Warsa

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum anti-rotavirus Immunoglobulin A (IgA) antibody concentration expressed as Geometric Mean Concentrations (GMCs).		Two months after Dose 2.	No
Secondary	Serum anti-rotavirus IgA antibody concentration expressed as GMCs in a subset of subjects.		Two months after Dose 1.	No
Secondary	Seroconversion rates to anti-rotavirus IgA antibody		Two months after Dose 1 (in a subset of subjects) and Dose 2 (all subjects).	No
Secondary	Vaccine take rates in a subset of subjects.		Two months after each dose	No
Secondary	Presence of rotavirus in stool samples in a subset of subjects		On the day of each vaccination and on planned days following each vaccination.	No
Secondary	For each type of solicited symptom, occurrence of the symptom		During the 8-day follow-up period after each vaccine dose	No
Secondary	Occurrence of unsolicited symptoms		During the 31-day follow-up period after each vaccine dose.	No
Secondary	Occurrence of serious adverse events		Throughout the study period.	No

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