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

NCT04481191 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: V260-0742020-003329-49
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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

  1 month postdose 3 of IPV (Month ~3.5)

• Percentage of Participants With Solicited Injection-Site Adverse Events

  Up to 7 days following each IPV vaccination

• Percentage of Participants With Solicited Systemic Adverse Events

  Up to 7 days following each RotaTeq and/or IPV vaccination

Study Arms (2)

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).

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).

Biological: RotaTeq (V260); Biological: IPV

Interventions

RotaTeq (V260) BIOLOGICAL

Live, pentavalent rotavirus vaccine administered as a 2 mL-dose oral solution

Also known as: RotaTeq, V260

Concomitant RotaTeq and IPV; Staggered RotaTeq and IPV

IPV BIOLOGICAL

0.5 mL dose IPV (Sabin strain based), administered via IM injection

Concomitant RotaTeq and IPV; Staggered RotaTeq and IPV

Eligibility Criteria

• Age: 48 Days - 63 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (1)

Yangchun Center For Disease Prevention And Control ( Site 0001)

Yangchun, Guangdong, 529600, China

Location

Related Publications (1)

• 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.

  PMID: 38509699 RESULT

Related Links

• Merck Clinical Trials Information

MeSH Terms

Interventions

RotaTeq; Rotavirus Vaccines

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Limitations and Caveats

Protocol Amendment 3 was issued after study completion. The purpose of the amendment was to update the Sponsor entity name and address.

Results Point of Contact

• Title: Clinical Trials Disclosure
• Organization: Merck Sharp & Dohme LLC

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2020
• First Posted: July 22, 2020
• Study Start: August 25, 2020
• Primary Completion: May 8, 2021
• Study Completion: May 8, 2021
• Last Updated: July 26, 2024
• Results First Posted: February 17, 2023

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)