Phase 2
N=100
A Study of Safety, Reactogenicity and Immunogenicity of HRV Vaccine in HIV Infected Infants in South Africa
Infections, Rotavirus
Bottom Line
View on ClinicalTrials.gov: NCT00263666 ↗Enrolled (actual)
100
Serious AEs
29.0%
Results posted
Mar 2009
Primary outcome: Primary: Number of Subjects Reporting Grade "2" or Grade "3" Fever, Vomiting or Diarrhea — 26; 28 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Rotarix (Biological); Placebo (Biological); Tritanrix-HB+Hib (Biological); Polio Sabin (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Feb 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Reporting Grade "2" or Grade "3" Fever, Vomiting or Diarrhea |
26; 28 | — |
| SECONDARY Number of Subjects Reporting Any Unsolicited Symptoms |
47; 48 | — |
| SECONDARY Number of Subjects Reporting Any Serious Adverse Events |
17; 12 | — |
| SECONDARY Number of Subjects Reporting Each Type of Solicited Symptom |
24; 25; 8; 8; 20; 19 | — |
| SECONDARY The Number of Subjects With no Evidence of Immunosuppression and Moderate/ Severe Suppression, Based on CD4+ Absolute Cell Count and CD4+ Percent |
1; 2; 12; 15; 37; 33 | — |
| SECONDARY Human Immunodeficiency Virus (HIV) Viral Load |
5.7; 5.7; 5.6; 5.7 | — |
| SECONDARY Number of Subjects Who Seroconverted Against Rotavirus |
12; 4 | — |
| SECONDARY Number of Subjects With Vaccine Take |
15; 7 | — |
| SECONDARY Serum Rotavirus Immunoglobulin A (IgA) Antibody Concentrations |
75.5 | — |
| SECONDARY Number of Subjects With Anti-polyribosyl Ribitol Phosphate (PRP) Antibody Concentrations More Than or Equal to the Cut-off Value |
20; 23; 20; 22 | — |
| SECONDARY Geometric Mean Concentration for Anti-PRP Antibodies |
4.641; 4.865 | — |
| SECONDARY Number of Subjects With Anti-diphtheria and Anti-tetanus Toxoids Antibody Concentrations More Than or Equal to the Cut-off Value |
19; 19; 23; 24 | — |
| SECONDARY Geometric Mean Concentration for Anti-diphtheria and Anti-tetanus Toxoids Antibodies |
1.457; 1.035; 0.283; 0.219 | — |
| SECONDARY Number of Subjects With Anti-hepatitis B (HBs) Antibody Concentrations More Than or Equal to the Cut-off Value |
15; 11 | — |
| SECONDARY Geometric Mean Concentration for Anti-HBs Antibodies |
25.6; 18.9 | — |
| SECONDARY Number of Subjects With Anti-Bordetella Pertussis (BPT) Antibody Concentrations More Than or Equal to the Cut-off Value |
19; 14 | — |
| SECONDARY Geometric Mean Concentration for Anti-BPT Antibodies |
28.8; 18.1 | — |
| SECONDARY Number of Subjects With Anti-polio Types 1, 2 and 3 Antibody Titers More Than or Equal to the Cut-off Value |
19; 15; 23; 21; 18; 15 | — |
| SECONDARY Geometric Mean Titer for Anti-polio Types 1, 2 and 3 Antibodies. |
90.5; 53.0; 142.6; 252.4; 44.7; 66.0 | — |
| SECONDARY Rotavirus Antigen Excretion in Stool Samples |
11; 5 | — |
| SECONDARY Rotavirus in Diarrheal Stool Samples |
4; 4 | — |
| SECONDARY Rotavirus Vaccine Strain Identification |
2; 0; 0; 1; 0; 1 | — |
| SECONDARY Enteric Pathogens Identification |
18; 24; 0; 0; 11; 10 | — |
| SECONDARY Number of Subjects With the RV in Stool Samples |
7; 0; 0; 0; 2; 1 | — |
Summary
The aim of this study is to evaluate the reactogenicity, safety and immunogenicity of GSK Biologicals' human rotavirus (HRV) vaccine given concomitantly with routine vaccines including OPV in HIV positive infants. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Eligibility Criteria
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 10 weeks of age at the time of the first vaccination.
- Written informed consent obtained from the parents or guardians of the subject
- Documented HIV status of the subject as confirmed by PCR.
- HIV asymptomatic and HIV mildly symptomatic; Stages I and II disease according to WHO's most recent classification for HIV stages in infants and children.
- Born after a gestation period of 36 to 42 weeks.
Exclusion Criteria
- Use of any investigational or non-registered 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.
- Previous routine vaccination except OPV, BCG and HBV vaccination at birth
- Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the GI tract or other serious medical condition as determined by the investigator.
- History of allergic disease or reaction likely to be exacerbated by any component of the vaccine.
- Acute disease at time of enrolment.
- Gastroenteritis within 7 days preceding the study vaccine administration.
- Previous confirmed occurrence of RV gastroenteritis.
- Other conditions which in the opinion of the investigator may potentially interfere with interpretation of study outcomes.
- HIV moderately and severely symptomatic: stages III and IV according to WHO's recent classification.
- Administration of immunoglobulins and/or blood products since birth or planned administration during the study period.
Data sourced from ClinicalTrials.gov (NCT00263666). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.