DiarrheaPhase 2/3ROTAVACNCT03602053
Study of BBIL's ROTAVAC® and ROTAVAC 5CM Vaccines in Zambia
A Phase 2/3 study testing ROTAVAC®, ROTAVAC 5D and Rotarix® in people with Diarrhea and Diarrhea Rotavirus, run by Centre for Infectious Disease Research in Zambia at 1 site in Zambia.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 8 weeksHealthy volunteers can take part
- Conditions the study is for
- Diarrhea, Diarrhea Rotavirus
- What is being tested?
- ROTAVAC®, ROTAVAC 5D and Rotarix®
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteZambia
- Study dates
- 22 Jan 2019to 4 Oct 2019
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 8 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy infant as established by medical history and clinical examination before entering the study.
- Age: 6-8 weeks (42-56 days, both days inclusive) confirmed by Immunization Record.
- Infants received age-appropriate EPI vaccines till enrolment.
- Ability and willingness to provide informed consent as per local consenting procedures.
- Parent can be contacted on phone and confirms intention to remain in the study area with the participant during the study period.
Who cannot join
- Presence of diarrhea or vomiting in the previous 72 hours or on the day of enrolment (temporary exclusion).
- Presence of fever on the day of enrolment (temporary exclusion).
- Acute disease at the time of enrolment (temporary exclusion).
- Concurrent participation in another clinical trial throughout the entire timeframe of this study.
- Presence of severe malnutrition (weight-for-height z-score < -3SD median).
- Any systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrine, immunological, dermatological, neurological, cancer or autoimmune disease) as determined by medical history and/or physical examination which would compromise the child's health or is likely to result in non-conformance to the protocol.
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- History of congenital abdominal disorders, intussusception, abdominal surgery
- Known or suspected impairment of immunological function based on medical history and physical examination.
- Prior receipt or intent to receive rotavirus and other age specified EPI vaccines outside of the study center and during study participation.
- A known sensitivity or allergy to any component of the study vaccine.
- Clinically detectable significant congenital or genetic defect.
- History of persistent diarrhea (defined as diarrhea more than 14 days).
- Participant's parents not able, available or willing to accept active follow-up by the study staff.
- Has received any immunoglobulin therapy and/or blood products since birth or planned administration during the study period.
- History of chronic administration (defined as more than 14 days) of immunosuppressants including corticosteroids. Infants on inhaled or topical steroids may be permitted to participate in the study.
- History of any neurologic disorders or seizures.
- Any medical condition in the parents/infants that, in the judgment of the investigator, would interfere with or serves as a contraindication to protocol adherence or a participant's parent's/legally acceptable representative's ability to give informed consent.
- Participant is a direct descendant (child or grandchild) of any person employed by the Sponsor, the CRO, the PI or study site personnel.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Randomized, Controlled, Single Centre, Phase IIb Study to Assess the Immunogenicity, Reactogenicity and Safety of Three Live Oral Rotavirus Vaccines, ROTAVAC® , ROTAVAC 5CM and Rotarix® in Healthy Zambian Infants
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.
Read the 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.
- Conditions
- Diarrhea, Diarrhea Rotavirus
- Being tested
- ROTAVAC®, ROTAVAC 5D, Rotarix®
- Keywords
- diarrhea, Rotavirus, ROTAVAC, Rotavirus vaccine
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ROTAVAC®Biological
0.5 ml of the vaccine will be administered orally thrice at 6, 10 and 14 weeks of age.
ROTAVAC 5DBiological
0.5 ml of the vaccine will be administered orally thrice at 6, 10 and 14 weeks of age.
Rotarix®Biological
1.5 ml of the liquid vaccine will be administered orally twice at 6 and 10 weeks of age.
| Study group | Role | What they receive |
|---|---|---|
| ROTAVAC 5D | Experimental | Bharat Biotech International Ltd's new Rotavirus vaccine, ROTAVAC 5D is a live, attenuated G9P[11] monovalent vaccine at a dose of 0.5mL containing NLT log 10^5.0 focus forming units (FFU) per dose. 5D is in liquid form. Receives: Biological: ROTAVAC 5D |
| ROTAVAC® | Experimental | Bharat Biotech International Ltd's licensed rotavirus vaccine, ROTAVAC® is a live, attenuated G9P[11] monovalent vaccine at a dose of 0.5mL containing NLT log 10^5.0 focus forming units (FFU) per dose. ROTAVAC® is in frozen form and is thawed till fully liquid prior to administration. Receives: Biological: ROTAVAC® |
| Rotarix® | Active comparator | GSK Biologicals' licensed rotavirus vaccine, Rotarix® is a live attenuated RIX4414 strain of human rotavirus of the G1P[8] type containing not less than 106.0 CCID50 (cell culture infectious dose 50%) of the RIX 4414 strain of human rotavirus. Receives: Biological: Rotarix® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric Mean Concentration Using WC3 as the Viral Lysate
GMC of serum anti-rotavirus IgA antibodies as measured by enzyme linked immunosorbent assay (ELISA) using WC3 (heterologous to vaccine strain) as the viral lysate. WC3 strain of rotavirus used in the ELISA assay was heterologous to the 116E strain contained in the vaccines ROTAVAC 5D® and ROTAVAC®.
Measured: 28 day after last dose of the study vaccine
Secondary outcomes (8)
Immediate Adverse Events
Percentage of participants reporting immediate adverse events after each vaccination
Measured: within 30 minutes' post-vaccination.
Solicited Adverse Events
Percentage of participants reporting solicited post-vaccination reactogenicity (fever, diarrhea, vomiting, decreased appetite, irritability, decreased activity level)
Measured: 7 day period after each vaccination.
Unsolicited Adverse Events
Percentage of participants reporting unsolicited AEs at a rate >5%.
Measured: From first vaccination through 4 weeks after the last vaccination.
Serious Adverse Events
Percentage of participants reporting SAEs
Measured: From first vaccination through 4 weeks after the last vaccination of each study participant. Immunogenicity
Seroconversion Rate in Each of the Three Arms as Measured by ELISA Using WC3 as the Viral Lysate
Seroconversion is defined as a post-vaccination serum anti-rotavirus IgA antibody concentration of at least 20 U/mL if a baseline concentration is < 20 U/mL or a post-vaccination serum anti-rotavirus IgA antibody concentration of ≥ 2-fold baseline level if a baseline concentration is ≥ 20 U/mL.
WC3 strain of rotavirus used in the ELISA assay was heterologous to the 116E strain contained in the vaccines ROTAVAC® and ROTAVAC 5D®.
Measured: 28 days after last dose of study vaccine.
Seropositivity Rate in Each of the Three Vaccine Arms as Measured by ELISA Using WC3 as the Viral Lysate
Seropositivity is defined as serum anti-rotavirus IgA antibody concentration ≥ 20 U/mL. WC3 strain of rotavirus used in the ELISA assay was heterologous to the 116E strain contained in the vaccines ROTAVAC® and ROTAVAC 5D®.
Measured: 28 days after last dose of study vaccine
Seroresponse Rate in Each of the Three Vaccine Arms as Measured by ELISA Using WC3 as the Viral Lysate
Seroresponse will be assessed as a four-fold, three-fold and two- fold rise in antibody concentration from baseline. Seroresponse will be assessed as a four-fold, three-fold and two-fold rise in antibody concentration from baseline. WC3 strain of rotavirus used in the ELISA assay was heterologous to the 116E strain contained in the vaccines ROTAVAC® and ROTAVAC 5D®.
Measured: 28 days after last dose of study vaccine
Geometric Mean Fold Rise (GMFR) in Each of the Three Vaccine Arms as Measured by ELISA Using WC3 as the Viral Lysate
GMFR in each of the ROTAVAC 5D®, ROTAVAC® and Rotarix® vaccine arms. WC3 strain of rotavirus used in the ELISA assay was heterologous to the 116E strain contained in the vaccines ROTAVAC® and ROTAVAC 5D®.
Measured: At 28 days after last dose of study vaccine in reference to baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start22 Jan 2019
- Primary completion4 Oct 2019
- Study completion4 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (40)Papers the sponsor has linked to this study.
- Other trials for DiarrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase IIb, single center, randomized, controlled, open label study
- Masking
- None (open label)
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Infectious Disease Research in Zambia
- Sponsor type
- University, hospital or other
- Collaborators
- PATH, Christian Medical College, Vellore, India, Children's Hospital Medical Center, Cincinnati, Bharat Biotech International Limited
- Responsible party
- Principal investigator, Roma Chilengi, Centre for Infectious Disease Research in Zambia
- Investigators
- Niraj Rathi, MD, Study director, PATH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03602053
- Sponsor's protocol ID
- CVIA 066
- Acronym
- ROTAVAC
- Status last verified
- Dec 2020
- First submitted
- 18 Jul 2018
- Last updated
- 19 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tate JE, Burton AH, Boschi-Pinto C, Parashar UD; World Health Organization-Coordinated Global Rotavirus Surveillance Network. Global, Regional, and National Estimates of Rotavirus Mortality in Children <5 Years of Age, 2000-2013. Clin Infect Dis. 2016 May 1;62 Suppl 2(Suppl 2):S96-S105. doi: 10.1093/cid/civ1013.
PubMed 27059362Atherly DE, Lewis KD, Tate J, Parashar UD, Rheingans RD. Projected health and economic impact of rotavirus vaccination in GAVI-eligible countries: 2011-2030. Vaccine. 2012 Apr 27;30 Suppl 1(Suppl 1):A7-14. doi: 10.1016/j.vaccine.2011.12.096.
PubMed 22520139Beres LK, Tate JE, Njobvu L, Chibwe B, Rudd C, Guffey MB, Stringer JS, Parashar UD, Chilengi R. A Preliminary Assessment of Rotavirus Vaccine Effectiveness in Zambia. Clin Infect Dis. 2016 May 1;62 Suppl 2(Suppl 2):S175-82. doi: 10.1093/cid/civ1206.
PubMed 27059353Liu L, Johnson HL, Cousens S, Perin J, Scott S, Lawn JE, Rudan I, Campbell H, Cibulskis R, Li M, Mathers C, Black RE; Child Health Epidemiology Reference Group of WHO and UNICEF. Global, regional, and national causes of child mortality: an updated systematic analysis for 2010 with time trends since 2000. Lancet. 2012 Jun 9;379(9832):2151-61. doi: 10.1016/S0140-6736(12)60560-1. Epub 2012 May 11.
PubMed 22579125Chilengi R, Simuyandi M, Beach L, Mwila K, Becker-Dreps S, Emperador DM, Velasquez DE, Bosomprah S, Jiang B. Association of Maternal Immunity with Rotavirus Vaccine Immunogenicity in Zambian Infants. PLoS One. 2016 Mar 14;11(3):e0150100. doi: 10.1371/journal.pone.0150100. eCollection 2016.
PubMed 26974432Tate JE, Yen C, Steiner CA, Cortese MM, Parashar UD. Intussusception Rates Before and After the Introduction of Rotavirus Vaccine. Pediatrics. 2016 Sep;138(3):e20161082. doi: 10.1542/peds.2016-1082. Epub 2016 Aug 24.
PubMed 27558938Madhi SA, Cunliffe NA, Steele D, Witte D, Kirsten M, Louw C, Ngwira B, Victor JC, Gillard PH, Cheuvart BB, Han HH, Neuzil KM. Effect of human rotavirus vaccine on severe diarrhea in African infants. N Engl J Med. 2010 Jan 28;362(4):289-98. doi: 10.1056/NEJMoa0904797.
PubMed 20107214Armah GE, Sow SO, Breiman RF, Dallas MJ, Tapia MD, Feikin DR, Binka FN, Steele AD, Laserson KF, Ansah NA, Levine MM, Lewis K, Coia ML, Attah-Poku M, Ojwando J, Rivers SB, Victor JC, Nyambane G, Hodgson A, Schodel F, Ciarlet M, Neuzil KM. Efficacy of pentavalent rotavirus vaccine against severe rotavirus gastroenteritis in infants in developing countries in sub-Saharan Africa: a randomised, double-blind, placebo-controlled trial. Lancet. 2010 Aug 21;376(9741):606-14. doi: 10.1016/S0140-6736(10)60889-6. Epub 2010 Aug 6.
PubMed 20692030Zaman K, Dang DA, Victor JC, Shin S, Yunus M, Dallas MJ, Podder G, Vu DT, Le TP, Luby SP, Le HT, Coia ML, Lewis K, Rivers SB, Sack DA, Schodel F, Steele AD, Neuzil KM, Ciarlet M. Efficacy of pentavalent rotavirus vaccine against severe rotavirus gastroenteritis in infants in developing countries in Asia: a randomised, double-blind, placebo-controlled trial. Lancet. 2010 Aug 21;376(9741):615-23. doi: 10.1016/S0140-6736(10)60755-6. Epub 2010 Aug 6.
PubMed 20692031Bhandari N, Rongsen-Chandola T, Bavdekar A, John J, Antony K, Taneja S, Goyal N, Kawade A, Kang G, Rathore SS, Juvekar S, Muliyil J, Arya A, Shaikh H, Abraham V, Vrati S, Proschan M, Kohberger R, Thiry G, Glass R, Greenberg HB, Curlin G, Mohan K, Harshavardhan GV, Prasad S, Rao TS, Boslego J, Bhan MK; India Rotavirus Vaccine Group. Efficacy of a monovalent human-bovine (116E) rotavirus vaccine in Indian infants: a randomised, double-blind, placebo-controlled trial. Lancet. 2014 Jun 21;383(9935):2136-43. doi: 10.1016/S0140-6736(13)62630-6. Epub 2014 Mar 12.
PubMed 24629994Isanaka S, Guindo O, Langendorf C, Matar Seck A, Plikaytis BD, Sayinzoga-Makombe N, McNeal MM, Meyer N, Adehossi E, Djibo A, Jochum B, Grais RF. Efficacy of a Low-Cost, Heat-Stable Oral Rotavirus Vaccine in Niger. N Engl J Med. 2017 Mar 23;376(12):1121-1130. doi: 10.1056/NEJMoa1609462.
PubMed 28328346Mpabalwani EM, Simwaka CJ, Mwenda JM, Mubanga CP, Monze M, Matapo B, Parashar UD, Tate JE. Impact of Rotavirus Vaccination on Diarrheal Hospitalizations in Children Aged <5 Years in Lusaka, Zambia. Clin Infect Dis. 2016 May 1;62 Suppl 2(Suppl 2):S183-7. doi: 10.1093/cid/civ1027.
PubMed 27059354Bishop R. Discovery of rotavirus: Implications for child health. J Gastroenterol Hepatol. 2009 Oct;24 Suppl 3:S81-5. doi: 10.1111/j.1440-1746.2009.06076.x.
PubMed 19799704Santos N, Hoshino Y. Global distribution of rotavirus serotypes/genotypes and its implication for the development and implementation of an effective rotavirus vaccine. Rev Med Virol. 2005 Jan-Feb;15(1):29-56. doi: 10.1002/rmv.448.
PubMed 15484186Kang G, Arora R, Chitambar SD, Deshpande J, Gupte MD, Kulkarni M, Naik TN, Mukherji D, Venkatasubramaniam S, Gentsch JR, Glass RI, Parashar UD; Indian Rotavirus Strain Surveillance Network. Multicenter, hospital-based surveillance of rotavirus disease and strains among indian children aged <5 years. J Infect Dis. 2009 Nov 1;200 Suppl 1:S147-53. doi: 10.1086/605031.
PubMed 19817593
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Controlled, Single Centre, Phase IIb Study to Assess the Immunogenicity, Reactogenicity and Safety of Three Live Oral Rotavirus Vaccines, ROTAVAC® , ROTAVAC 5CM and Rotarix® in Healthy Zambian Infants
- ClinicalTrials.gov ID
- NCT03602053
- Acronym / sponsor ID
- ROTAVAC / CVIA 066
- Conditions
- Diarrhea, Diarrhea Rotavirus
- Keywords
- diarrhea, Rotavirus, ROTAVAC, Rotavirus vaccine
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Centre for Infectious Disease Research in ZambiaUniversity, hospital or other
- Collaborators
- PATH, Christian Medical College, Vellore, India, Children's Hospital Medical Center, Cincinnati, Bharat Biotech International Limited
- Study start
- 22 Jan 2019 (actual)
- Primary completion
- 4 Oct 2019 (actual)
- Study completion
- 4 Oct 2019 (actual)
- First posted
- 26 Jul 2018 (actual)
- Results
- Posted 19 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Phase IIb, single center, randomized, controlled, open label study
| Arm | Type | Receives |
|---|---|---|
| ROTAVAC 5D | Experimental | Biological: ROTAVAC 5DBharat Biotech International Ltd's new Rotavirus vaccine, ROTAVAC 5D is a live, attenuated G9P[11] monovalent vaccine at a dose of 0.5mL containing NLT log 10^5.0 focus forming units (FFU) per dose. 5D is in liquid form. |
| ROTAVAC® | Experimental | Biological: ROTAVAC®Bharat Biotech International Ltd's licensed rotavirus vaccine, ROTAVAC® is a live, attenuated G9P[11] monovalent vaccine at a dose of 0.5mL containing NLT log 10^5.0 focus forming units (FFU) per dose. ROTAVAC® is in frozen form and is thawed till fully liquid prior to administration. |
| Rotarix® | Active comparator | Biological: Rotarix®GSK Biologicals' licensed rotavirus vaccine, Rotarix® is a live attenuated RIX4414 strain of human rotavirus of the G1P[8] type containing not less than 106.0 CCID50 (cell culture infectious dose 50%) of the RIX 4414 strain of human rotavirus. |
Who may qualify
- Ages
- 6 to 8 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Healthy infant as established by medical history and clinical examination before entering the study.
- Age: 6-8 weeks (42-56 days, both days inclusive) confirmed by Immunization Record.
- Infants received age-appropriate EPI vaccines till enrolment.
- Ability and willingness to provide informed consent as per local consenting procedures.
- Parent can be contacted on phone and confirms intention to remain in the study area with the participant during the study period.
Key exclusion criteria (18 listed)
- Presence of diarrhea or vomiting in the previous 72 hours or on the day of enrolment (temporary exclusion).
- Presence of fever on the day of enrolment (temporary exclusion).
- Acute disease at the time of enrolment (temporary exclusion).
- Concurrent participation in another clinical trial throughout the entire timeframe of this study.
- Presence of severe malnutrition (weight-for-height z-score < -3SD median).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ROTAVAC®0.5 ml of the vaccine will be administered orally thrice at 6, 10 and 14 weeks of age. | Biological | ROTAVAC® |
| ROTAVAC 5D0.5 ml of the vaccine will be administered orally thrice at 6, 10 and 14 weeks of age. | Biological | ROTAVAC 5D |
| Rotarix®1.5 ml of the liquid vaccine will be administered orally twice at 6 and 10 weeks of age. | Biological | Rotarix® |
Primary outcome
Geometric Mean Concentration Using WC3 as the Viral Lysate
Time frame: 28 day after last dose of the study vaccine
GMC of serum anti-rotavirus IgA antibodies as measured by enzyme linked immunosorbent assay (ELISA) using WC3 (heterologous to vaccine strain) as the viral lysate. WC3 strain of rotavirus used in the ELISA assay was heterologous to the 116E strain contained in the vaccines ROTAVAC 5D® and ROTAVAC®.
8 secondary outcomes
Immediate Adverse Events
Time frame: within 30 minutes' post-vaccination.
Solicited Adverse Events
Time frame: 7 day period after each vaccination.
Unsolicited Adverse Events
Time frame: From first vaccination through 4 weeks after the last vaccination.
Serious Adverse Events
Time frame: From first vaccination through 4 weeks after the last vaccination of each study participant. Immunogenicity
Seroconversion Rate in Each of the Three Arms as Measured by ELISA Using WC3 as the Viral Lysate
Time frame: 28 days after last dose of study vaccine.
Seropositivity Rate in Each of the Three Vaccine Arms as Measured by ELISA Using WC3 as the Viral Lysate
Time frame: 28 days after last dose of study vaccine
Seroresponse Rate in Each of the Three Vaccine Arms as Measured by ELISA Using WC3 as the Viral Lysate
Time frame: 28 days after last dose of study vaccine
Geometric Mean Fold Rise (GMFR) in Each of the Three Vaccine Arms as Measured by ELISA Using WC3 as the Viral Lysate
Time frame: At 28 days after last dose of study vaccine in reference to baseline.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27059362Tate JE, Burton AH, Boschi-Pinto C, Parashar UD; World Health Organization-Coordinated Global Rotavirus Surveillance Network. Global, Regional, and National Estimates of Rotavirus Mortality in Children <5 Years of Age, 2000-2013. Clin Infect Dis. 2016 May 1;62 Suppl 2(Suppl 2):S96-S105. doi: 10.1093/cid/civ1013.
- Background: PubMed 22520139Atherly DE, Lewis KD, Tate J, Parashar UD, Rheingans RD. Projected health and economic impact of rotavirus vaccination in GAVI-eligible countries: 2011-2030. Vaccine. 2012 Apr 27;30 Suppl 1(Suppl 1):A7-14. doi: 10.1016/j.vaccine.2011.12.096.
- Background: PubMed 27059353Beres LK, Tate JE, Njobvu L, Chibwe B, Rudd C, Guffey MB, Stringer JS, Parashar UD, Chilengi R. A Preliminary Assessment of Rotavirus Vaccine Effectiveness in Zambia. Clin Infect Dis. 2016 May 1;62 Suppl 2(Suppl 2):S175-82. doi: 10.1093/cid/civ1206.
- Background: PubMed 22579125Liu L, Johnson HL, Cousens S, Perin J, Scott S, Lawn JE, Rudan I, Campbell H, Cibulskis R, Li M, Mathers C, Black RE; Child Health Epidemiology Reference Group of WHO and UNICEF. Global, regional, and national causes of child mortality: an updated systematic analysis for 2010 with time trends since 2000. Lancet. 2012 Jun 9;379(9832):2151-61. doi: 10.1016/S0140-6736(12)60560-1. Epub 2012 May 11.
- Background: PubMed 26974432Chilengi R, Simuyandi M, Beach L, Mwila K, Becker-Dreps S, Emperador DM, Velasquez DE, Bosomprah S, Jiang B. Association of Maternal Immunity with Rotavirus Vaccine Immunogenicity in Zambian Infants. PLoS One. 2016 Mar 14;11(3):e0150100. doi: 10.1371/journal.pone.0150100. eCollection 2016.
- Background: PubMed 27558938Tate JE, Yen C, Steiner CA, Cortese MM, Parashar UD. Intussusception Rates Before and After the Introduction of Rotavirus Vaccine. Pediatrics. 2016 Sep;138(3):e20161082. doi: 10.1542/peds.2016-1082. Epub 2016 Aug 24.
- Background: PubMed 20107214Madhi SA, Cunliffe NA, Steele D, Witte D, Kirsten M, Louw C, Ngwira B, Victor JC, Gillard PH, Cheuvart BB, Han HH, Neuzil KM. Effect of human rotavirus vaccine on severe diarrhea in African infants. N Engl J Med. 2010 Jan 28;362(4):289-98. doi: 10.1056/NEJMoa0904797.
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- Rotarix (Product Information).Link provided by the sponsor.
- Rotateq (Product Information).Link provided by the sponsor.
- PATH welcomes new promising study results for rotavirus vaccine candidate.Link provided by the sponsor.
- Bharat Biotech receives National Technology Award for Rotavac from President of IndiaLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Niraj Rathi, MD study director
PATH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing ROTAVAC®, ROTAVAC 5D and Rotarix® in people with Diarrhea and Diarrhea Rotavirus, run by Centre for Infectious Disease Research in Zambia at 1 site in Zambia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Geometric Mean Concentration Using WC3 as the Viral Lysate (time frame: 28 day after last dose of the study vaccine). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03602053, which also lists 40 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2020; AzTrials last refreshed its copy on 26 Oct 2026.