Trial reportHuman vaccines & immunotherapeutics2013
Immunogenicity and safety of the pentavalent human-bovine (WC3) reassortant rotavirus vaccine (PRV) in Indian infants.
Trial report in Human vaccines & immunotherapeutics, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00496054 (Evaluation of Safety,Tolerability and Immunogenicity of Vaccination With Rotateq), which is not on this map. Cited by 4 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Evaluation of Safety,Tolerability and Immunogenicity of Vaccination With Rotateq (V260) in Healthy Infants in India
Who cites it
4 citing papers in PubMed, 17 citations in OpenAlex.
- A randomized Phase I/II study to evaluate safety and reactogenicity of a heat-stable rotavirus vaccine in healthy adults followed by evaluation of the safety, reactogenicity, and immunogenicity in infants.Human vaccines & immunotherapeutics · 2020Trial
- Trial
- Overview of the Development, Impacts, and Challenges of Live-Attenuated Oral Rotavirus Vaccines.Vaccines · 2020Review
- Nitazoxanide in Acute Rotavirus Diarrhea: A Randomized Control Trial from a Developing Country.Journal of tropical medicine · 2017Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 5 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo evaluate the immunogenicity and safety of a pentavalent rotavirus vaccine (PRV) in Indian infants. STUDY
designOpen-label, single-arm multicentric study.
settingHospital facilities (out patients): SUBJECTS: One hundred and ten (110) healthy Indian infants were enrolled between the ages of 6 weeks and 12 weeks.
interventionThree doses of oral pentavalent rotavirus vaccine (PRV) were administered with an interval of 4 to 10 weeks (28 to 70 days).
main outcome measuresImmunogenicity of PRV was based on the proportion of infants exhibiting a > 3-fold rise in serum anti rotavirus IgA antibodies (from pre dose 1 to 14 days post dose 3). Safety was evaluated for 14 days after each dose.
resultsOf the 110 infants enrolled, 83% exhibited at least a 3-fold rise (seroconversion) in serum anti rotavirus IgA antibodies. There were no clinically significant adverse events reported.
conclusionsA 3-dose regimen of PRV was found to be immunogenic and well tolerated in healthy Indian infants. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov; NCT00496054:
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Registered trials
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