Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00432380
Other study ID # 109216
Secondary ID 2015-001544-11
Status Completed
Phase Phase 2
First received
Last updated
Start date March 9, 2007
Est. completion date September 4, 2007

Study information

Verified date December 2019
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will provide data on the immune response and safety of GSK Biologicals' HRV liquid vaccine when given along with the routine infant immunizations in Philippines.


Recruitment information / eligibility

Status Completed
Enrollment 375
Est. completion date September 4, 2007
Est. primary completion date September 4, 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 5 Weeks to 10 Weeks
Eligibility Inclusion Criteria:

- Healthy infants between, and including, 5-10 weeks of age at the time of the first dose of HRV liquid vaccine or placebo.

- Birth weight of the subject should be > 2000 grams.

- Written informed consent obtained from the parent or guardian of the subject.

Exclusion Criteria:

- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.

- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.

- Planned administration/ administration of a vaccine not foreseen by the study protocol except for DTPw, HBV and OPV vaccines within 14 days before each dose of HRV liquid vaccine or placebo and ending 14 days after. BCG is administered at birth according to the local EPI.

- Concurrently participating in another clinical study, at any time during the study period.

- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).

- History of allergic disease or reactions likely to be exacerbated by any component of the HRV liquid vaccine or placebo.

- Acute disease at the time of enrolment.

- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.

Study Design


Intervention

Biological:
Rotarix™
oral doses
Placebo
oral dose

Locations

Country Name City State
Philippines GSK Investigational Site Muntinlupa

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Philippines, 

References & Publications (1)

Anh DD, Carlos CC, Thiem DV, Hutagalung Y, Gatchalian S, Bock HL, Smolenov I, Suryakiran PV, Han HH. Immunogenicity, reactogenicity and safety of the human rotavirus vaccine RIX4414 (Rotarix™) oral suspension (liquid formulation) when co-administered with expanded program on immunization (EPI) vaccines in Vietnam and the Philippines in 2006-2007. Vaccine. 2011 Mar 3;29(11):2029-36. doi: 10.1016/j.vaccine.2011.01.018. Epub 2011 Jan 21. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Seroconverted Subjects for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibody Seroconversion was defined as the appearance of anti-RV IgA antibody concentrations greater than or equal to (=) 20 units per milliliter (U/mL) in subjects initially (i.e. prior to the first dose of Rotarix™ vaccine or placebo) seronegative, when administered concomitantly with the second and third routine EPI immunization. This outcome measure only concerns subjects in the Placebo-Rotarix-Rotarix Group. At Month 3
Secondary Number of Seroconverted Subjects for Anti-RV IgA Antibody Seroconversion was defined as the appearance of anti-RV IgA antibody concentrations = 20 U/mL in subjects initially (i.e. prior to the first dose of Rotarix™ vaccine or placebo) seronegative, when administered concomitantly with the first and third routine EPI immunization. This outcome measure only concerns subjects in the Rotarix-Placebo-Rotarix Group. At Month 3
Secondary Serum IgA Antibody Concentrations Against Rotavirus Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in units per milliliter (U/mL). This outcome measure only concerns subjects in Placebo-Rotarix-Rotarix and Rotarix-Placebo-Rotarix Groups. At Month 3
Secondary Number of Subjects Reporting Grade 2 or Grade 3 Fever, Vomiting or Diarrhea Any symptom = occurrence of the symptom (i.e. fever or vomiting or diarrhea) regardless of intensity grade or relationship to vaccination. Grade 2 fever = rectal temperature greater than (>) 38.5 - less than or equal to (=) 39.5degrees Celsius (°C) or axillary temperature > 38.0 - = 39.0°C. Grade 3 fever = rectal temperature > 39.5°C or axillary temperature > 39.0°C. Grade 2 vomiting = 2 episodes of vomiting/ day. Grade 3 vomiting = 3 or more episodes of vomiting/ day. Grade 2 diarrhea = 4-5 looser than normal stools/ day. Grade 3 diarrhea = 6 or more looser than normal stools/ day. During the 8-day (Days 0-7) period following each dose of study vaccine or placebo and across doses
Secondary Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Assessed solicited general symptoms were cough/runny nose, diarrhea, fever (rectally), irritability, loss of appetite and vomiting. Any = any solicited symptom irrespective of intensity grade or relationship to vaccination. Grade 3 cough/runny nose = cough/runny nose which prevented daily activity. Grade 2 diarrhea: 4-5 looser than normal stools/ day. Grade 3 diarrhea = = 6 looser than normal stools/ day. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 2 vomiting= 2 episodes of vomiting/ day. Grade 3 vomiting = = 3 episodes of vomiting/ day. Related = symptom considered by the investigator to have a causal relationship to study vaccination. During the 8-day (Days 0-7) period following each dose of study vaccine or placebo and across doses
Secondary Number of Subjects Reporting RV in Gastroenteritis (GE) Episodes Presence of RV (vaccine strain or wild-type) in GE stools. From Dose 1 of study vaccine or placebo (at Day 0) up to Month 3
Secondary Number of Subjects Reporting Any Unsolicited Adverse Event (AE) An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. During the 31-day (Days 0-30) period following any study vaccine dose or placebo
Secondary Number of Subjects With Serious Adverse Events (SAEs) Serious adverse events (SAEs) assessed include any untoward medical occurrences that results in death, are life threatening, requires hospitalization or prolongation of hospitalization, result in disability/incapacity or congenital anomaly/birth defect in the offspring of a study subject. During the entire study period (from Day 0 to Month 3)
See also
  Status Clinical Trial Phase
Completed NCT01435967 - Observational Study on Rotavirus Gastroenteritis Epidemiology, Impact of Lyophilised vs. Liquid Formulation of Rotarix™ N/A
Completed NCT00345956 - To Evaluate Immunogenicity, Reactogenicity & Safety of 2 Doses of GSK Bio HRV Liquid Vaccine Given to Infants (Vietnam) Phase 3
Completed NCT00370318 - Prophylactic Antipyretic Treatment in Children Receiving Pneumococcal Conjugate and Standard Infant Vaccines Phase 3
Completed NCT00140686 - To Test 2 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Infants in Co-administration With Specific Childhood Vaccines Phase 3
Completed NCT00383903 - Evaluate Safety & Immunogenicity of 2 or 3 Doses of GSK HRV Vaccine in Healthy Infants in South Africa Phase 2
Completed NCT00750893 - Evaluation of Reactogenicity and Safety of GSK Biologicals' Rotarix (Human Rotavirus Vaccine) in Infants
Completed NCT00533507 - Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6 to 8 Weeks of Age Phase 3
Completed NCT00363545 - To Assess Immunogenicity, Reactogenicity & Safety of 2 Formulations of GSK's HRV Vaccine as 2-dose Vaccination (Infants) Phase 3
Completed NCT02914184 - Evaluation of Immunogenicity and Safety of Two Formulations of GSK Biologicals' Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 Weeks Phase 3
Completed NCT00489567 - Hospital-based Surveillance to Collect Prospective Data to Estimate the Disease Burden of Severe RV GE in Sweden N/A
Completed NCT01733862 - Study to Assess the Impact of Vaccination on Hospitalizations and Outpatient Visits Due to Rotavirus Gastroenteritis
Completed NCT00779779 - Evaluation of Reactogenicity and Safety of GSK Biologicals' Rotarix™ (Human Rotavirus Vaccine) in Infants
Completed NCT00382772 - A Study in Infants to Test Two Preparations (Freeze-dried or Liquid) of the Rotavirus Vaccine (HRV Vaccine). Phase 3
Completed NCT00729001 - Study of Two Doses of GSK Biologicals' Live Attenuated HRV Vaccine (Two Different Formulations) in Healthy Infants. Phase 2
Completed NCT00353366 - To Evaluate Safety & Reactogenicity of GSK Bio's Human Rotavirus (HRV) Vaccine in Filipino Infants at Least 6 Weeks of Age at First Vaccination
Completed NCT01198769 - Immunogenicity and Safety Study of Rotarix TM in Taiwanese Infants Who Received Hepatitis B Immunoglobulin After Birth. Phase 4
Completed NCT00385320 - Evaluate Protective Efficacy of Diff Strengths of Human Rotavirus Vaccine After Admn of 2 Doses to Infants Aged 2 Months Phase 2
Completed NCT01563159 - Number of Rotavirus (RV) Related Hospitalizations in Belgium - Season 2010-2011 N/A
Completed NCT01339221 - Epidemiological, Observational and Post Marketing Study of Rotarix™ in Children With Severe Gastroenteritis in Belgium N/A
Completed NCT00653198 - Effectiveness of Rotarix™ Against Rotavirus Severe Gastroenteritis (RV SGE) in Infants in Panama N/A