Study of BBIL's ROTAVAC® and ROTAVAC 5CM Vaccines in Zambia
Condition: Diarrhea; Diarrhea Rotavirus
MeSH terms: Diarrhea
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The study is being conducted to evaluate and compare the immunogenicity of ROTAVAC® and
      ROTAVAC 5D 28 days after the last dose of the vaccine, when administered to infants in a
      three-dose schedule at 6, 10 and 14 weeks of age.

      The study will also assess the reactogenicity of the vaccine 7 days after each vaccination
      and safety from first vaccination up to 4 weeks after the last vaccination with ROTAVAC® and
      ROTAVAC 5D, and of Rotarix® when administered to infants in a two-dose schedule at 6 and 10
      weeks of age.
    

Detailed description: 
      This study is designed as a Phase IIb, single center, randomized, controlled, open label
      study with 3 groups of infants (n=150 per group) receiving either three doses of ROTAVAC®
      three doses of ROTAVAC 5D or two doses of Rotarix®. 450 participants will be randomized
      (1:1:1) to receive ROTAVAC®, ROTAVAC 5D or Rotarix®. The three doses of ROTAVAC® and ROTAVAC
      5D will be administered at 6, 10 and 14 weeks of age whereas two doses of Rotarix® will be
      administered at 6 and 10 weeks of age. All vaccines will be administered concomitantly with
      EPI vaccines including Diphtheria, Tetanus, Pertussis, Haemophilus influenzae type b and
      Hepatitis B vaccine (DTwP-Hib-HepB), Pneumococcal conjugate vaccine and OPV at 6, 10 and 14
      weeks and IPV at week 14 (when switched to in Zambia). The participants will be monitored for
      30 minutes following vaccine administration for immediate adverse events.

      A blood sample will be obtained from all the participating infants before first vaccination
      and four weeks after the last vaccine dose. This would mean that the blood sample will be
      collected at approximately 14 weeks of age for infants in the Rotarix® arm and 18 weeks for
      infants in the ROTAVAC® groups.

      Enhanced passive/Active surveillance for vaccine reactogenicity (solicited reactions) over
      the 7-day period after each vaccination will be conducted on all infants. In addition,
      surveillance for unsolicited AEs, SAEs including intussusception will be carried out over the
      period between first vaccination and four weeks after the last vaccination on all infants.

      The study will compare the immunogenicity of the two formulations of ROTAVAC® i.e. ROTAVAC®
      vs. ROTAVAC 5D and will descriptively analyze the immune response to Rotarix®. Primary
      immunogenicity analysis of all samples will be based on a validated ELISA which uses strain
      WC3 as a substrate. A subset of the samples (50 pairs/arms) collected will also be tested by
      a validated ELISA which uses strain 89-12 (G1P8 virus) as a substrate. This trial will
      generate immunogenicity and safety data on ROTAVAC® and ROTAVAC 5D outside of India.
      Presentation of data to Zambian Ministry of Health, WHO and in peer reviewed open access
      publications will be key audiences targeted for communication of results.
    

Intervention name(s): ROTAVAC®; ROTAVAC 5D; Rotarix®
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 0.5 ml of the vaccine will be administered orally thrice at 6, 10 and 14 weeks of age.; 0.5 ml of the vaccine will be administered orally thrice at 6, 10 and 14 weeks of age.; 1.5 ml of the liquid vaccine will be administered orally twice at 6 and 10 weeks of age.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Phase IIb, single center, randomized, controlled, open label study
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: diarrhea; Rotavirus; ROTAVAC; Rotavirus vaccine