Rotavirus Infection of ChildrenPhase 3NCT04010448
A Trial to Assess the Safety, Immunogenicity and Efficacy of a Trivalent Rotavirus P2-VP8 Subunit Vaccine in Prevention of Severe Rotavirus Gastroenteritis in Healthy Infants in Africa and India
A Phase 3 study testing TV P2-VP8 and Rotarix in people with Rotavirus Infection of Children, run by PATH at 1 site in Zambia.
Trial summary
The trial will be a multinational, randomized, double-blind, double-dummy, endpoint driven, group-sequential, active comparator-controlled study, in which participating infants will be randomized 1:1 to receive either: 1) 90 µg of the TV P2-VP8 vaccine IM plus oral placebo, or 2) Rotarix® per os (PO) plus IM placebo. Read more about this study
- Who is it for?
- Ages 6 to 8 weeksHealthy volunteers can take part
- Conditions the study is for
- Rotavirus Infection of Children
- What is being tested?
- TV P2-VP8 and Rotarix
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,200 participants
- Where
- 1 siteZambia
- Study dates
- 10 Oct 2019to 15 Dec 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 infants as established by medical history and clinical examination before entering the study
- Age: ≥6 and <8 weeks at the time of first study vaccination (42 days through 55 days old, inclusive, with the day after birth considered 1-day old)
- Parental/legal guardian's ability and willingness to provide written informed consent
- Intention of the participants' parents to remain in the area with the child during the study period
Who cannot join
- Acute disease at the time of first study vaccination - temporary exclusion
- Presence of fever on the day of first study vaccination (axillary temperature >37.6oC) - temporary exclusion
- Concurrent participation in another clinical trial throughout the entire timeframe for this study (participation in non-interventional observational study is allowed if there is no blood draw)
- Presence of severe malnutrition (weight-for-height z-score ≤-3SD median, per WHO published child growth standards) or 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 that would compromise the participant's health or is likely to result in nonconformance to the protocol
- History of premature birth (<37 weeks gestation) and/or birth weight of <2.5 kg
- History of congenital abdominal disorders, intussusception, or abdominal surgery
Show all 16Show fewer
- Prior receipt of rotavirus vaccine
- Known sensitivity or allergy to any components of the study vaccine
- Contraindication to any EPI/UIP vaccine
- History of anaphylactic reaction
- Major congenital or genetic defect
- Parents not able, available or willing to accept active weekly follow-up by the study staff
- Receipt of any immunoglobulin therapy and/or blood products
- Nursing infants whose mother are receiving immunosuppressive biologicals
- History of chronic administration (defined as more than 14 days) of immunosuppressant medications, including corticosteroids (those on inhaled or topical steroids may be permitted to participate in the study)
- Any medical condition in the participant or parents that, in the judgment of the investigator, would interfere with or serves as a contraindication to protocol adherence or a parents' ability to give informed consent
Trial locations and contacts
1 site in 1 country.
Zambia1 site, 1 recruiting
- Recruiting
Centre for Infectious Disease Research in Zambia (CIDRZ)
Lusaka
Roma Chilengi, MD
Caroline Chisenga, PhD
About this study
Official title: A Phase 3 Double-blind, Randomized, Active Comparator-controlled, Group-sequential, Multinational Trial to Assess the Safety, Immunogenicity and Efficacy of a Trivalent Rotavirus P2-VP8 Subunit Vaccine in Prevention of Severe Rotavirus Gastroenteritis in Healthy Infants
The trial will be a multinational, randomized, double-blind, double-dummy, endpoint driven, group-sequential, active comparator-controlled study, in which participating infants will be randomized 1:1 to receive either: 1) 90 µg of the TV P2-VP8 vaccine IM plus oral placebo, or 2) Rotarix® per os (PO) plus IM placebo. Participants will receive three doses of TV P2-VP8/placebo IM and two doses of Rotarix®/placebo PO at monthly intervals starting at ≥6 to <8 weeks of age, administered concomitantly with EPI/UIP vaccines. To maintain the blind, infants allocated to the TV P2-VP8 vaccine arm will receive both TV P2-VP8 IM as well as oral placebo vaccine, and infants allocated to receive Rotarix® will receive both Rotarix® PO and placebo IM. Active surveillance for episodes of gastroenteritis (GE) will be conducted throughout the study, through weekly contact with participants' parents. Unsolicited AEs grade ≥ 2 through 28 days after the last study vaccination will be recorded in the study database, as will data for SAEs (including intussusception) throughout the study.
- Conditions
- Rotavirus Infection of Children
- Being tested
- TV P2-VP8, Rotarix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TV P2-VP8Biological
90 µg of the TV P2-VP8 vaccine IM plus oral placebo administered on study days 1, 29 and 57
RotarixBiological
Rotarix® PO plus IM placebo administered on study days 1, 29 and 57
| Study group | Role | What they receive |
|---|---|---|
| TV P2-VP8 | Experimental | Not described Receives: Biological: TV P2-VP8 |
| Rotarix® | Active comparator | Not described Receives: Biological: Rotarix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of laboratory confirmed cases of severe rotavirus gastroenteritis (SRVGE; any strain)
SRVGE is defined by a Vesikari score of >11 (primary analysis to be performed once >99 cases are identified with onset at least 2 weeks after receipt of third study vaccination)
Measured: For cases with onset at least 2 weeks after 3rd study vaccination and onset at any time after first vaccination; for all events within the first 2 years of life
Number of serious adverse events (SAEs), including intussusception
Measured: Through 28 days after the last dose of study vaccine
Number of Adverse Events (AEs) > or = to grade 2
Measured: Through 28 days after the last dose of study vaccine
Secondary outcomes (5)
Number of laboratory confirmed cases of very severe rotavirus gastroenteritis (VSRVGE; any strain)
VSRVGE is defined by a Vesikari score of >15
Measured: For cases with onset at least 2 weeks after 3rd study vaccination and onset at any time after first vaccination; for all events within the first 2 years of life
Number of P-type specific (P[4], P[6] and P[8]) laboratory confirmed cases of SRVGE and VSRGE
Measured: For cases with onset at least 2 weeks after 3rd study vaccination and onset at any time after first vaccination; for all events within the first 2 years of life
Number of laboratory confirmed cases of rotavirus gastroenteritis (any strain) of any severity
Measured: For cases with onset at least 2 weeks after 3rd study vaccination and onset at any time after first vaccination; for all events within the first 2 years of life
Number of laboratory confirmed cases hospitalized for RVGE (any severity)
Measured: For cases with onset at least 2 weeks after 3rd study vaccination and onset at any time after first vaccination; for all events within the first 2 years of life
Incidence of SRVGE and VSRVGE per 100 children-years
Measured: For cases with onset at least 2 weeks after 3rd study vaccination and onset at any time after first vaccination; for all events within the first 2 years of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2019
- Study start10 Oct 2019
- Primary completion15 Dec 2025 (estimated)
- Study completion15 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rotavirus Infection of ChildrenStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participating infants will be randomized 1:1 to receive either: 1) 90 µg of the TV P2-VP8 vaccine IM plus oral placebo, or 2) Rotarix® PO plus IM placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PATH
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, SK Bioscience Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- George Armah, PhD, Principal investigator, Noguchi Memorial Institute for Medical Research, University of Ghana, LegonDesiree Witte, MD, Principal investigator, Malawi-Liverpool-Wellcome Trust (MLW) Clinical Research ProgrammeRoma Chilengi, MD, Principal investigator, Centre for Infectious Disease Research in Zambia (CIDRZ), Lusaka
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04010448
- Sponsor's protocol ID
- CVIA 061
- Status last verified
- Apr 2021
- First submitted
- 3 Jul 2019
- Last updated
- 9 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Summary results for primary and secondary objectives
Publications
Tewari T, Armah G, Cunliffe NA, Chisenga CC, Witte D, Kukula V, Jere KC, Simuyandi M, Damanka S, Mwinjiwa E, Kazimbaya K, Atuguba F, Williams J, Chilengi R, Csedrik J, Gast C, Fix A, Cryz S. Safety, immunogenicity, and relative efficacy of a parenteral trivalent rotavirus subunit vaccine candidate (TV P2-VP8) in healthy Ghanaian, Malawian, and Zambian infants. Vaccine. 2026 Jan 5;70:128019. doi: 10.1016/j.vaccine.2025.128019. Epub 2025 Nov 29.
PubMed 41319434
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Double-blind, Randomized, Active Comparator-controlled, Group-sequential, Multinational Trial to Assess the Safety, Immunogenicity and Efficacy of a Trivalent Rotavirus P2-VP8 Subunit Vaccine in Prevention of Severe Rotavirus Gastroenteritis in Healthy Infants
- ClinicalTrials.gov ID
- NCT04010448
- Acronym / sponsor ID
- CVIA 061
- Conditions
- Rotavirus Infection of Children
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8,200 participants (estimated)
- Lead sponsor
- PATHUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, SK Bioscience Co., Ltd.
- Study start
- 10 Oct 2019 (actual)
- Primary completion
- 15 Dec 2025 (estimated)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 8 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The trial will be a multinational, randomized, double-blind, double-dummy, endpoint driven, group-sequential, active comparator-controlled study, in which participating infants will be randomized 1:1 to receive either: 1) 90 µg of the TV P2-VP8 vaccine IM plus oral placebo, or 2) Rotarix® per os (PO) plus IM placebo. Participants will receive three doses of TV P2-VP8/placebo IM and two doses of Rotarix®/placebo PO at monthly intervals starting at ≥6 to <8 weeks of age, administered concomitantly with EPI/UIP vaccines. To maintain the blind, infants allocated to the TV P2-VP8 vaccine arm will receive both TV P2-VP8 IM as well as oral placebo vaccine, and infants allocated to receive Rotarix® will receive both Rotarix® PO and placebo IM. Active surveillance for episodes of gastroenteritis (GE) will be conducted throughout the study, through weekly contact with participants' parents. Unsolicited AEs grade ≥ 2 through 28 days after the last study vaccination will be recorded in the study database, as will data for SAEs (including intussusception) throughout the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participating infants will be randomized 1:1 to receive either: 1) 90 µg of the TV P2-VP8 vaccine IM plus oral placebo, or 2) Rotarix® PO plus IM placebo.
| Arm | Type | Receives |
|---|---|---|
| TV P2-VP8 | Experimental | Biological: TV P2-VP8 |
| Rotarix® | Active comparator | Biological: Rotarix |
Who may qualify
- Ages
- 6 to 8 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Healthy infants as established by medical history and clinical examination before entering the study
- Age: ≥6 and <8 weeks at the time of first study vaccination (42 days through 55 days old, inclusive, with the day after birth considered 1-day old)
- Parental/legal guardian's ability and willingness to provide written informed consent
- Intention of the participants' parents to remain in the area with the child during the study period
Key exclusion criteria (16 listed)
- Acute disease at the time of first study vaccination - temporary exclusion
- Presence of fever on the day of first study vaccination (axillary temperature >37.6oC) - temporary exclusion
- Concurrent participation in another clinical trial throughout the entire timeframe for this study (participation in non-interventional observational study is allowed if there is no blood draw)
- Presence of severe malnutrition (weight-for-height z-score ≤-3SD median, per WHO published child growth standards) or 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 that would compromise the participant's health or is likely to result in nonconformance to the protocol
- History of premature birth (<37 weeks gestation) and/or birth weight of <2.5 kg
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 |
|---|---|---|
| TV P2-VP890 µg of the TV P2-VP8 vaccine IM plus oral placebo administered on study days 1, 29 and 57 | Biological | TV P2-VP8 |
| RotarixRotarix® PO plus IM placebo administered on study days 1, 29 and 57 | Biological | Rotarix® |
Primary outcome
Number of laboratory confirmed cases of severe rotavirus gastroenteritis (SRVGE; any strain)
Time frame: For cases with onset at least 2 weeks after 3rd study vaccination and onset at any time after first vaccination; for all events within the first 2 years of life
SRVGE is defined by a Vesikari score of >11 (primary analysis to be performed once >99 cases are identified with onset at least 2 weeks after receipt of third study vaccination)
Number of serious adverse events (SAEs), including intussusception
Time frame: Through 28 days after the last dose of study vaccine
Number of Adverse Events (AEs) > or = to grade 2
Time frame: Through 28 days after the last dose of study vaccine
5 secondary outcomes
Number of laboratory confirmed cases of very severe rotavirus gastroenteritis (VSRVGE; any strain)
Time frame: For cases with onset at least 2 weeks after 3rd study vaccination and onset at any time after first vaccination; for all events within the first 2 years of life
Number of P-type specific (P[4], P[6] and P[8]) laboratory confirmed cases of SRVGE and VSRGE
Time frame: For cases with onset at least 2 weeks after 3rd study vaccination and onset at any time after first vaccination; for all events within the first 2 years of life
Number of laboratory confirmed cases of rotavirus gastroenteritis (any strain) of any severity
Time frame: For cases with onset at least 2 weeks after 3rd study vaccination and onset at any time after first vaccination; for all events within the first 2 years of life
Number of laboratory confirmed cases hospitalized for RVGE (any severity)
Time frame: For cases with onset at least 2 weeks after 3rd study vaccination and onset at any time after first vaccination; for all events within the first 2 years of life
Incidence of SRVGE and VSRVGE per 100 children-years
Time frame: For cases with onset at least 2 weeks after 3rd study vaccination and onset at any time after first vaccination; for all events within the first 2 years of life
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2021.
- Derived from this study: PubMed 41319434Tewari T, Armah G, Cunliffe NA, Chisenga CC, Witte D, Kukula V, Jere KC, Simuyandi M, Damanka S, Mwinjiwa E, Kazimbaya K, Atuguba F, Williams J, Chilengi R, Csedrik J, Gast C, Fix A, Cryz S. Safety, immunogenicity, and relative efficacy of a parenteral trivalent rotavirus subunit vaccine candidate (TV P2-VP8) in healthy Ghanaian, Malawian, and Zambian infants. Vaccine. 2026 Jan 5;70:128019. doi: 10.1016/j.vaccine.2025.128019. Epub 2025 Nov 29.
- Individual participant dataSharing planned: Yes. Summary results for primary and secondary objectives
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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.
George Armah, PhD principal investigator
Noguchi Memorial Institute for Medical Research, University of Ghana, Legon
Desiree Witte, MD principal investigator
Malawi-Liverpool-Wellcome Trust (MLW) Clinical Research Programme
Roma Chilengi, MD principal investigator
Centre for Infectious Disease Research in Zambia (CIDRZ), Lusaka
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TV P2-VP8 and Rotarix in people with Rotavirus Infection of Children, run by PATH 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 4 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 9 Apr 2021. 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 phase mean?
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joanne Csedrik, RN, MPH (+1-202-540-4496, jcsedrik@path.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of laboratory confirmed cases of severe rotavirus gastroenteritis (SRVGE; any strain) (time frame: For cases with onset at least 2 weeks after 3rd study vaccination and onset at any time after first vaccination; for all events within the first 2 years of life). The study lists 3 primary outcomes in all. 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 NCT04010448, which also lists 1 linked publication.
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 9 Apr 2021.