Prevention of Rotavirus Gastroenteritis in Infants and Children Caused by Serotypes G1, G2, G3, G4, and G9Phase 3NCT04481191

Immunogenicity and Safety of Concomitant and Non-Concomitant Administration of RotaTeq® (V260) and Inactivated Poliomyelitis Vaccine in Healthy Chinese Infants (V260-074)

A Phase 3 study testing RotaTeq (V260) and IPV in people with Prevention of Rotavirus Gastroenteritis in Infants and Children Caused by Serotypes G1, G2, G3, G4, and G9, run by Merck Sharp & Dohme LLC at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 48 to 63 daysHealthy volunteers can take part
Conditions the study is for: Prevention of Rotavirus Gastroenteritis in Infants and Children Caused by Serotypes G1, G2, G3, G4, and G9
What is being tested?: RotaTeq (V260) and IPV
Type of treatment: Vaccines, Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 400 participants
Where: 1 siteChina
Study dates: 25 Aug 2020to 8 May 2021
Phase: Phase 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 48 to 63 days
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Healthy Chinese infant 48 days to 63 days of age.
Infant's legally acceptable representative provides written informed consent for the study.

Who cannot join

History of rotavirus disease, congenital gastrointestinal disorders, chronic diarrhea, failure to thrive, or abdominal surgery.
History of intussusception.
History of poliomyelitis.
Clinical evidence of active gastrointestinal illness. Note: Infants with gastroesophageal reflux disease [GERD] may participate in the study if the GERD is well controlled with or without medication.
Known or suspected impairment of immunological function, including severe combined immunodeficiency disease (SCID).
Has a fever, with an axillary temperature ≥37.5°C (or equivalent) at the time of vaccination or within 24 hours prior to vaccination. Note: The Visit 1 may be rescheduled after complete resolution of febrile illness.

Show all 21Show fewer

Has acute disease.
Has underlying diseases such as cardiovascular, renal, liver, or blood disease.
History of known hypersensitivity to any components of rotavirus vaccine and/or IPV.
Uncontrolled epilepsy, encephalopathy, seizure, or other progressive neurological diseases.
Known thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections.
Resides in a household with an immunocompromised person, including individuals with congenital immunodeficiency (including SCID), human immunodeficiency virus (HIV) infection, leukemia, lymphoma, multiple myeloma, generalized malignance, chronic renal failure, organ or bone marrow transplantation, or with those receiving immunosuppressive chemotherapy including long-term systemic corticosteroids.
Any condition, which in the opinion of the investigator, may interfere with the evaluation of the study objectives.
Prior administration of any rotavirus vaccines or poliovirus vaccines.
Has received inactivated or recombinant vaccines within 14 days prior to Visit 1 or live vaccines within 28 days prior to Visit 1.
Has received an investigational or non-registered product other than study vaccines or is planning to use such product during the study.
Has received immunosuppressive therapies including systemic (intramuscular, oral, or intravenous) corticosteroids. Note: Participants using non-systemic corticosteroids (e.g., topical, ophthalmic, and inhaled) are considered eligible for the study.
Has received a blood transfusion or blood products, including immunoglobulins or is planning to receive such product during the study.
Has participated in another interventional study prior to Visit 1 or expected to anytime during the study.
The infant's legally acceptable representative is unlikely to adhere to the study procedures, keep appointments or is planning to permanently relocate from the area prior to the completion of the study or to leave for an extended period when study visits would need to be scheduled.
Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling, or child) who is an investigational site or Sponsor staff member directly involved with this study.

Trial locations and contacts

1 site in 1 country.

China1 site

Yangchun Center For Disease Prevention And Control ( Site 0001)
Yangchun, Guangdong, 529600

Other trials in China

About this study

Official title: A Phase 3 Randomized, Open-Label, Clinical Trial to Study the Immunogenicity and Safety of Concomitant and Non-Concomitant Administration of V260 and Inactivated Poliomyelitis Vaccine (IPV) in Chinese Healthy Infants

This study will evaluate the immunogenicity and safety of concomitant administration of RotaTeq® (V260) and inactivated poliomyelitis vaccine (IPV) in Chinese infants. Its primary objective is to demonstrate that the immunogenicity of IPV in the concomitant-use group is non-inferior to the immunogenicity of IPV in the staggered-use group. The hypothesis to be tested is: The seroconversion percentage at 1 month post dose 3 for poliovirus types 1, 2, and 3 in the concomitant-use group is non-inferior to those of the staggered-use group.

Conditions: Prevention of Rotavirus Gastroenteritis in Infants and Children Caused by Serotypes G1, G2, G3, G4, and G9
Being tested: RotaTeq (V260), IPV

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RotaTeq (V260)Biological
Also called RotaTeq, V260
Live, pentavalent rotavirus vaccine administered as a 2 mL-dose oral solution
IPVBiological
0.5 mL dose IPV (Sabin strain based), administered via IM injection

Study groups in NCT04481191
Study group	Role	What they receive
Concomitant RotaTeq and IPV	Experimental	Participants will receive RotaTeq (2 mL oral dose) and IPV (0.5 mL intramuscular [IM] injection ) concomitantly at Visit 2 (15 to 21 days after Visit 1 [Day 1]), Visit 4 (30 to 42 days after Visit 2), and Visit 6 (30 to 42 days after Visit 4). Receives: Biological: RotaTeq (V260); Biological: IPV
Staggered RotaTeq and IPV	Active comparator	Participants will receive RotaTeq (2 mL oral dose) at Visit 1 (Day 1), Visit 3 (30 to 42 days after Visit 1), and Visit 5 (30 to 42 days after Visit 3); and IPV (0.5 mL IM injection) at Visit 2 (15 to 21 days Visit 1), Visit 4 (30 to 42 days after Visit 2), and Visit 6 (30 to 42 days after Visit 4). Receives: Biological: RotaTeq (V260); Biological: IPV

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants Achieving Neutralizing Antibody Seroconversion to Poliovirus Types 1, 2, and 3 at 1 Month Post Dose 3 of IPV
The immunogenicity of IPV was measured using poliovirus serum neutralizing antibody assay of the National Institutes for Food and Drug Control (NIFDC), Beijing, China. Serum conversion was defined as antibody titer ≥1:8 post-vaccination in baseline seronegative participants or ≥4-fold increase in titer post-vaccination in baseline seropositive participants.
Measured: Baseline and 1 month postdose 3 of IPV (Month ~3.5)

Secondary outcomes (6)

Geometric Mean Titers (GMTs) of Neutralizing Antibody to Poliovirus Types 1, 2, and 3 at 1 Month Post Dose 3 of IPV
The immune response to IPV was measured using poliovirus serum neutralizing antibody assay of the NIFDC, Beijing, China.
Measured: 1 month postdose 3 of IPV (Month ~3.5)
Percentage of Participants Achieving Neutralizing Antibody Titers ≥1:8 for Poliovirus Types 1, 2, and 3 at 1 Month Post Dose 3 of IPV
The immune response to IPV was measured using poliovirus serum neutralizing antibody assay of the NIFDC, Beijing, China.
Measured: 1 month post dose 3 of IPV (Month ~3.5)
Percentage of Participants Achieving Neutralizing Antibody Titers ≥1:64 for Poliovirus Types 1, 2, and 3 at 1 Month Post Dose 3 of IPV
The immune response to IPV was measured using poliovirus serum neutralizing antibody assay of the NIFDC, Beijing, China.
Measured: 1 month postdose 3 of IPV (Month ~3.5)
Percentage of Participants With Solicited Injection-Site Adverse Events
Solicited injection-site adverse events (AEs) included erythema, swelling, induration, and pain at the IPV injection-site.
Measured: Up to 7 days following each IPV vaccination
Percentage of Participants With Solicited Systemic Adverse Events
Solicited systemic AEs included diarrhea, vomiting, and elevated temperature (axillary temperature ≥37.5º C).
Measured: Up to 7 days following each RotaTeq and/or IPV vaccination
Percentage of Participants With Serious Adverse Events (SAEs)
The percentage of participants with SAEs is presented. An SAE is an AE that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or another important medical event.
Measured: Up to approximately 3.5 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Aug 20208 May 2021

First posted22 Jul 2020
Study start25 Aug 2020
Primary completion8 May 2021
Study completion8 May 2021

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 (1)Papers the sponsor has linked to this study.
Other trials for Prevention of Rotavirus Gastroenteritis in Infants and Children Caused by Serotypes G1, G2, G3, G4, and G9Studies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
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
Masking: None (open label)
Enrolment: 400 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04481191
Sponsor's protocol ID: V260-074
Other IDs: V260-074, 2020-003329-49
Status last verified: Jul 2024
First submitted: 20 Jul 2020
Last updated: 26 Jul 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

Chen S, Ying Z, Liu Y, Li Y, Yu Y, Huang M, Huang Z, Ou Z, Liao Y, Zhang Y, Liu G, Zhao W, Fu R, Shou Q, Zheng M, Liao X, Tu Y, Stek J, Hartzel J, Li C, Zhang J. A phase 3 randomized, open-label study evaluating the immunogenicity and safety of concomitant and staggered administration of a live, pentavalent rotavirus vaccine and an inactivated poliomyelitis vaccine in healthy infants in China. Hum Vaccin Immunother. 2024 Dec 31;20(1):2324538. doi: 10.1080/21645515.2024.2324538. Epub 2024 Mar 20.
PubMed 38509699

Study at a glance

From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3 Randomized, Open-Label, Clinical Trial to Study the Immunogenicity and Safety of Concomitant and Non-Concomitant Administration of V260 and Inactivated Poliomyelitis Vaccine (IPV) in Chinese Healthy Infants
ClinicalTrials.gov ID: NCT04481191
Acronym / sponsor ID: V260-074
Conditions: Prevention of Rotavirus Gastroenteritis in Infants and Children Caused by Serotypes G1, G2, G3, G4, and G9
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 400 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 25 Aug 2020 (actual)
Primary completion: 8 May 2021 (actual)
Study completion: 8 May 2021 (actual)
First posted: 22 Jul 2020 (actual)
Results: Posted 17 Feb 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Concomitant RotaTeq and IPV	Experimental	Biological: RotaTeq (V260), Biological: IPVParticipants will receive RotaTeq (2 mL oral dose) and IPV (0.5 mL intramuscular [IM] injection ) concomitantly at Visit 2 (15 to 21 days after Visit 1 [Day 1]), Visit 4 (30 to 42 days after Visit 2), and Visit 6 (30 to 42 days after Visit 4).
Staggered RotaTeq and IPV	Active comparator	Biological: RotaTeq (V260), Biological: IPVParticipants will receive RotaTeq (2 mL oral dose) at Visit 1 (Day 1), Visit 3 (30 to 42 days after Visit 1), and Visit 5 (30 to 42 days after Visit 3); and IPV (0.5 mL IM injection) at Visit 2 (15 to 21 days Visit 1), Visit 4 (30 to 42 days after Visit 2), and Visit 6 (30 to 42 days after Visit 4).

Who may qualify

Ages: 48 to 63 days
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (2 listed)

Healthy Chinese infant 48 days to 63 days of age.
Infant's legally acceptable representative provides written informed consent for the study.

Key exclusion criteria (21 listed)

History of rotavirus disease, congenital gastrointestinal disorders, chronic diarrhea, failure to thrive, or abdominal surgery.
History of intussusception.
History of poliomyelitis.
Clinical evidence of active gastrointestinal illness. Note: Infants with gastroesophageal reflux disease [GERD] may participate in the study if the GERD is well controlled with or without medication.
Known or suspected impairment of immunological function, including severe combined immunodeficiency disease (SCID).

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
RotaTeq (V260)Also: RotaTeq, V260Live, pentavalent rotavirus vaccine administered as a 2 mL-dose oral solution	Biological	Concomitant RotaTeq and IPV, Staggered RotaTeq and IPV
IPV0.5 mL dose IPV (Sabin strain based), administered via IM injection	Biological	Concomitant RotaTeq and IPV, Staggered RotaTeq and IPV

Primary outcome

Percentage of Participants Achieving Neutralizing Antibody Seroconversion to Poliovirus Types 1, 2, and 3 at 1 Month Post Dose 3 of IPV
Time frame: Baseline and 1 month postdose 3 of IPV (Month ~3.5)
The immunogenicity of IPV was measured using poliovirus serum neutralizing antibody assay of the National Institutes for Food and Drug Control (NIFDC), Beijing, China. Serum conversion was defined as antibody titer ≥1:8 post-vaccination in baseline seronegative participants or ≥4-fold increase in titer post-vaccination in baseline seropositive participants.

6 secondary outcomes

Geometric Mean Titers (GMTs) of Neutralizing Antibody to Poliovirus Types 1, 2, and 3 at 1 Month Post Dose 3 of IPV
Time frame: 1 month postdose 3 of IPV (Month ~3.5)
Percentage of Participants Achieving Neutralizing Antibody Titers ≥1:8 for Poliovirus Types 1, 2, and 3 at 1 Month Post Dose 3 of IPV
Time frame: 1 month post dose 3 of IPV (Month ~3.5)
Percentage of Participants Achieving Neutralizing Antibody Titers ≥1:64 for Poliovirus Types 1, 2, and 3 at 1 Month Post Dose 3 of IPV
Time frame: 1 month postdose 3 of IPV (Month ~3.5)
Percentage of Participants With Solicited Injection-Site Adverse Events
Time frame: Up to 7 days following each IPV vaccination
Percentage of Participants With Solicited Systemic Adverse Events
Time frame: Up to 7 days following each RotaTeq and/or IPV vaccination
Percentage of Participants With Serious Adverse Events (SAEs)
Time frame: Up to approximately 3.5 months

Results and safety

Results posted to the registry on 17 Feb 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Concomitant RotaTeq and IPV	200	185
Staggered RotaTeq and IPV	200	190

Primary outcome: Percentage of Participants Achieving Neutralizing Antibody Seroconversion to Poliovirus Types 1, 2, and 3 at 1 Month Post Dose 3 of IPV

Time frame: Baseline and 1 month postdose 3 of IPV (Month ~3.5). Number. Unit: Percentage of Participants

Measure	Concomitant RotaTeq and IPV n = 180	Staggered RotaTeq and IPV n = 187
Poliovirus Type 1	98.9	100.0
Poliovirus Type 2	98.3	99.5
Poliovirus Type 3	100.0	99.5

Concomitant RotaTeq and IPV vs Staggered RotaTeq and IPV: Mean Difference (Final Values): -1.1 (95% CI -4.0 to 0.9), p < 0.001, Unstratified Miettinen & Nurminen method
Concomitant RotaTeq and IPV vs Staggered RotaTeq and IPV: Mean Difference (Final Values): -1.1 (95% CI -4.3 to 1.5), p < 0.001, Unstratified Miettinen & Nurminen method
Concomitant RotaTeq and IPV vs Staggered RotaTeq and IPV: Mean Difference (Final Values): 0.5 (95% CI -1.6 to 3.0), p < 0.001, Unstratified Miettinen & Nurminen method

Population analysed: Participants who received the 3 scheduled doses of study vaccination, adhered to guidelines for vaccine administration, provided baseline and post-vaccination blood samples within the acceptable day range, and did not have important protocol deviations are included.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to approximately 3.5 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Concomitant RotaTeq and IPV	7 of 189 (3.7%)	123 of 189 (65.1%)	0 of 189
Staggered RotaTeq and IPV	11 of 200 (5.5%)	143 of 200 (71.5%)	0 of 200

Limitations and caveats (from the sponsor): Protocol Amendment 3 was issued after study completion. The purpose of the amendment was to update the Sponsor entity name and address.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 38509699Chen S, Ying Z, Liu Y, Li Y, Yu Y, Huang M, Huang Z, Ou Z, Liao Y, Zhang Y, Liu G, Zhao W, Fu R, Shou Q, Zheng M, Liao X, Tu Y, Stek J, Hartzel J, Li C, Zhang J. A phase 3 randomized, open-label study evaluating the immunogenicity and safety of concomitant and staggered administration of a live, pentavalent rotavirus vaccine and an inactivated poliomyelitis vaccine in healthy infants in China. Hum Vaccin Immunother. 2024 Dec 31;20(1):2324538. doi: 10.1080/21645515.2024.2324538. Epub 2024 Mar 20.
Merck Clinical Trials InformationLink provided by the sponsor.
Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

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.

Medical Director study director

Merck Sharp & Dohme LLC

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 2 inclusion and 21 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 26 Jul 2024. 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 China. 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?

Yes. Results are posted in the registry (first posted 17 Feb 2023). 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?

Percentage of Participants Achieving Neutralizing Antibody Seroconversion to Poliovirus Types 1, 2, and 3 at 1 Month Post Dose 3 of IPV (time frame: Baseline and 1 month postdose 3 of IPV (Month ~3.5)). 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 NCT04481191, 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 26 Jul 2024.