Trial reportPediatrics2016
Safety and Immunogenicity of Sequential Rotavirus Vaccine Schedules.
Trial report in Pediatrics, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
21 citing papers in PubMed, 3 syntheses or guidelines pooled it, 38 citations in OpenAlex.
- Vaccines for preventing rotavirus diarrhoea: vaccines in use.The Cochrane database of systematic reviews · 2021Pooled it
- Vaccines for preventing rotavirus diarrhoea: vaccines in use.The Cochrane database of systematic reviews · 2019Pooled it
- Vaccines for preventing rotavirus diarrhoea: vaccines in use.The Cochrane database of systematic reviews · 2019Pooled it
- A Phase 3 study to assess the safety and immunogenicity of a quadrivalent meningococcal conjugate vaccine (MenACYW-TT) co-administered with routine pediatric vaccines in healthy infants in the USA and Puerto Rico.Human vaccines & immunotherapeutics · 2025Trial
- Immunogenicity of RV1 and RV5 vaccines administered in standard and interchangeable mixed schedules: a randomized, double-blind, non-inferiority clinical trial in Mexican infants.Frontiers in public health · 2024Trial
- Head-to-head comparison of the immunogenicity of RotaTeq and Rotarix rotavirus vaccines and factors associated with seroresponse in infants in Bangladesh: a randomised, controlled, open-label, parallel, phase 4 trial.The Lancet. Infectious diseases · 2022Trial
- Safety and immunogenicity of the Rotavac and Rotasiil rotavirus vaccines administered in an interchangeable dosing schedule among healthy Indian infants: a multicentre, open-label, randomised, controlled, phase 4, non-inferiority trial.The Lancet. Infectious diseases · 2022Trial
- Immunogenicity and safety of two monovalent rotavirus vaccines, ROTAVAC® and ROTAVAC 5D® in Zambian infants.Vaccine · 2021Trial
- Effect of Concomitant Antibiotic and Vaccine Administration on Serologic Responses to Rotavirus Vaccine.Journal of the Pediatric Infectious Diseases Society · 2020Trial
- Review
- Inclusion of Women, Children, the Elderly, and Individuals With Underlying Medical Conditions: Prioritizing Vulnerable Populations in Clinical Research.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025Article
- Historical Advances in Clinical Trial Design and Expanding Representation as the New Frontier for Innovation.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025Article
- Vaccine and Treatment Evaluation Units: A Historical Perspective.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025Article
- Future Goals and Long-term Vision of the Infectious Diseases Clinical Research Consortium/Vaccine and Treatment Evaluation Unit Network.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025Article
- Anti-rotavirus antibody measurement in a rotavirus vaccine trial: Choice of vaccine antigen in immunoassays does matter.Human vaccines & immunotherapeutics · 2023Article
- Article
- Systematic review of the effect of additional doses of oral rotavirus vaccine on immunogenicity and reduction in diarrhoeal disease among young children.EClinicalMedicine · 2022Article
- Understanding Rotavirus Vaccine Efficacy and Effectiveness in Countries with High Child Mortality.Vaccines · 2022Review
- Monoreassortant Rotaviruses of Multiple G Types Are Differentially Neutralized by Sera From Infants Vaccinated With ROTARIX and RotaTeq.The Journal of infectious diseases · 2021Article
- Product review of the rotavirus vaccines ROTASIIL, ROTAVAC, and Rotavin-M1.Human vaccines & immunotherapeutics · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
18 authors at 12 institutions in 2 countries.
Funding
Abstract
BACKGROUND AND
objectivesAlthough both licensed rotavirus vaccines are safe and effective, it is often not possible to complete the schedule by using the same vaccine formulation. The goal of this study was to investigate the noninferiority of the immune responses to the 2 licensed rotavirus vaccines when administered as a mixed schedule compared with administering a single vaccine formulation alone.
methodsRandomized, multicenter, open-label study. Healthy infants (6-14 weeks of age) were randomized to receive rotavirus vaccines in 1 of 5 different schedules (2 using a single vaccine for all doses, and 3 using mixed schedules). The group receiving only the monovalent rotavirus vaccine received 2 doses of vaccine and the other 4 groups received 3 doses of vaccine. Serum for immunogenicity testing was obtained 1 month after the last vaccine dose and the proportion of seropositive children (rotavirus immunoglobulin A ≥20 U/mL) were compared in all the vaccine groups.
resultsBetween March 2011 and September 2013, 1393 children were enrolled and randomized. Immune responses to all the sequential mixed vaccine schedules were shown to be noninferior when compared with the 2 single vaccine reference groups. The proportion of children seropositive to at least 1 vaccine antigen at 1 month after vaccination ranged from 77% to 96%, and was not significantly different among all the study groups. All schedules were well tolerated.
conclusionsMixed schedules are safe and induced comparable immune responses when compared with the licensed rotavirus vaccines given alone.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.