Dataset Information

Immunogenicity and safety of porcine circovirus-free human rotavirus vaccine in healthy infants: a phase III, randomized trial.

ABSTRACT:

Background

Porcine circovirus type 1 (PCV-1) material was detected in the human rotavirus vaccine (HRV) in 2010. In this study (NCT02914184) we compared immunogenicity and safety of the PCV-free HRV vaccine (PCV-free HRV) with HRV. PCV-free HRV is an HRV with no detection of PCV-1 and PCV-2 according to the limit of detection of the tests used.

Methods

Healthy infants 6-12 weeks of age were randomized (1:1:1:1) to receive 2 doses of 1 of the 3 lots of PCV-free HRV or HRV. The study objectives were to demonstrate lot-to-lot consistency of the PCV-free HRV and non-inferiority of PCV-free HRV as compared to HRV in terms of immunogenicity, 1-2 months post-dose 2. Reactogenicity and safety were also assessed.

Results

Overall, 1612 infants were enrolled and 1545 completed the study. Study objectives were demonstrated since the pre-defined criteria were met. Among participants receiving PCV-free HRV and HRV, 79.27% and 81.76% seroconverted and geometric mean concentrations were 159.5 and 152.8 U/mL, respectively. The incidences of adverse events and serious adverse events were similar between the pooled PCV-free HRV and HRV groups.

Conclusions

The 3 PCV-free HRV lots demonstrated consistency and PCV-free HRV was non-inferior compared to HRV in terms of immunogenicity.

SUBMITTER: Salamanca de la Cueva I

PROVIDER: S-EPMC9200154 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

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Publications

Immunogenicity and safety of porcine circovirus-free human rotavirus vaccine in healthy infants: a phase III, randomized trial.

Salamanca de la Cueva Ignacio I Pahud Barbara B Huang Li-Min LM Leonardi Michael M Garcia-Sicilia José J Céspedes Javier J Abdelnour Arturo A Tamura Tsuyoshi T Kuroki Haruo H Chiu Nan-Chang NC Virta Miia M Kokko Satu S Horn Michael M Panzer Falko F Kim Jong-Hyun JH Jin Lee L Moerman Leentje L Debacq Christophe C Parra Jose J Ugarte Ana A Bi Dan D

The Journal of infectious diseases 20200504

<h4>Background</h4>Porcine circovirus type 1 (PCV-1) material was detected in the human rotavirus vaccine (HRV) in 2010. In this study (NCT02914184) we compared immunogenicity and safety of the PCV-free HRV vaccine (PCV-free HRV) with HRV. PCV-free HRV is an HRV with no detection of PCV-1 and PCV-2 according to the limit of detection of the tests used.<h4>Methods</h4>Healthy infants 6-12 weeks of age were randomized (1:1:1:1) to receive 2 doses of 1 of the 3 lots of PCV-free HRV or HRV. The stud ...[more]

PMID: 32365189

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Dataset Information

Immunogenicity and safety of porcine circovirus-free human rotavirus vaccine in healthy infants: a phase III, randomized trial.

Background

Methods

Results

Conclusions

Publications

Immunogenicity and safety of porcine circovirus-free human rotavirus vaccine in healthy infants: a phase III, randomized trial.

Similar Datasets

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