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CompletedNCT04481191Updated Jul 26, 2024Results posted

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 interventional study of RotaTeq (V260) and IPV in Prevention of Rotavirus Gastroenteritis in Infants and Children Caused by Serotypes G1, G2, G3, G4, and G9, sponsored by Merck Sharp & Dohme LLC. Completed at 1 site in China. Open to participants aged 48 Days to 63 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-26.

Sponsored by Merck Sharp & Dohme LLC · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
48 Days to 63 Days
Sex
All
01

Study 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.

02

Conditions studied

  • Prevention of Rotavirus Gastroenteritis in Infants and Children Caused by Serotypes G1, G2, G3, G4, and G9
03

Who can participate

Ages eligible
48 Days to 63 Days
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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.
04

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
400 participants (actual)

Study arms

  • Experimental
    Concomitant RotaTeq and IPV

    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

  • Active comparator
    Staggered RotaTeq and IPV

    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

  • BiologicalRotaTeq (V260)

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

    Also known as: RotaTeq, V260

  • BiologicalIPV

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

05

What researchers measure

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.

    Time frame: Baseline and 1 month postdose 3 of IPV (Month ~3.5)

Secondary outcomes

  1. 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.

    Time frame: 1 month postdose 3 of IPV (Month ~3.5)

  2. 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.

    Time frame: 1 month post dose 3 of IPV (Month ~3.5)

  3. 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.

    Time frame: 1 month postdose 3 of IPV (Month ~3.5)

  4. 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.

    Time frame: Up to 7 days following each IPV vaccination

  5. Percentage of Participants With Solicited Systemic Adverse Events

    Solicited systemic AEs included diarrhea, vomiting, and elevated temperature (axillary temperature ≥37.5º C).

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

  6. 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.

    Time frame: Up to approximately 3.5 months

06

Results

Posted Feb 17, 2023
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.

Participant flow

Participant flow — Overall Study
MilestoneConcomitant RotaTeq and IPVStaggered RotaTeq and IPV
Started200200
≥1 v260 vaccination189200
Completed185190
Not completed1510
Withdrew: Withdrawn by parent/guardian1510

Outcome measures

PrimaryPercentage 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.

Time frame:
Baseline and 1 month postdose 3 of IPV (Month ~3.5)
Reported as:
Number · Percentage of Participants
Percentage of Participants Achieving Neutralizing Antibody Seroconversion to Poliovirus Types 1, 2, and 3 at 1 Month Post Dose 3 of IPV
Percentage of ParticipantsConcomitant RotaTeq and IPVStaggered RotaTeq and IPV
Poliovirus Type 198.9100.0
Poliovirus Type 298.399.5
Poliovirus Type 3100.099.5
Statistical analysis
  • Concomitant RotaTeq and IPV vs Staggered RotaTeq and IPV · Unstratified Miettinen & Nurminen method · p = < 0.001 (One-sided p-value) · Mean difference (final values): -1.1 · 95% CI -4.0 to 0.9
  • Concomitant RotaTeq and IPV vs Staggered RotaTeq and IPV · Unstratified Miettinen & Nurminen method · p = < 0.001 (One-sided p-value) · Mean difference (final values): -1.1 · 95% CI -4.3 to 1.5
  • Concomitant RotaTeq and IPV vs Staggered RotaTeq and IPV · Unstratified Miettinen & Nurminen method · p = < 0.001 (One-sided p-value) · Mean difference (final values): 0.5 · 95% CI -1.6 to 3.0
SecondaryGeometric 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.

Time frame:
1 month postdose 3 of IPV (Month ~3.5)
Reported as:
Geometric mean · Titers
Geometric Mean Titers (GMTs) of Neutralizing Antibody to Poliovirus Types 1, 2, and 3 at 1 Month Post Dose 3 of IPV
TitersConcomitant RotaTeq and IPVStaggered RotaTeq and IPV
Poliovirus Type 15600.80 ± 4898.465344.24 ± 4657.51
Poliovirus Type 21059.83 ± 951.131122.43 ± 1002.74
Poliovirus Type 33405.56 ± 3033.933261.69 ± 2913.70
SecondaryPercentage 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.

Time frame:
1 month post dose 3 of IPV (Month ~3.5)
Reported as:
Number · Percentage of Participants
Percentage of Participants Achieving Neutralizing Antibody Titers ≥1:8 for Poliovirus Types 1, 2, and 3 at 1 Month Post Dose 3 of IPV
Percentage of ParticipantsConcomitant RotaTeq and IPVStaggered RotaTeq and IPV
Poliovirus Type 1100.0 ± 98.0100.0 ± 98.0
Poliovirus Type 2100.0 ± 98.0100.0 ± 98.0
Poliovirus Type 3100.0 ± 98.0100.0 ± 98.0
SecondaryPercentage 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.

Time frame:
1 month postdose 3 of IPV (Month ~3.5)
Reported as:
Number · Percentage of Participants
Percentage of Participants Achieving Neutralizing Antibody Titers ≥1:64 for Poliovirus Types 1, 2, and 3 at 1 Month Post Dose 3 of IPV
Percentage of ParticipantsConcomitant RotaTeq and IPVStaggered RotaTeq and IPV
Poliovirus Type 1100.00 ± 98.0100.0 ± 98.0
Poliovirus Type 2100.0 ± 98.0100.0 ± 98.0
Poliovirus Type 3100.0 ± 98.0100.0 ± 98.0
SecondaryPercentage 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.

Time frame:
Up to 7 days following each IPV vaccination
Reported as:
Number · Percentage of Participants
Percentage of Participants With Solicited Injection-Site Adverse Events
Percentage of ParticipantsConcomitant RotaTeq and IPVStaggered RotaTeq and IPV
Percentage of Participants With Solicited Injection-Site Adverse Events25.423.0
SecondaryPercentage of Participants With Solicited Systemic Adverse Events

Solicited systemic AEs included diarrhea, vomiting, and elevated temperature (axillary temperature ≥37.5º C).

Time frame:
Up to 7 days following each RotaTeq and/or IPV vaccination
Reported as:
Number · Percentage of Participants
Percentage of Participants With Solicited Systemic Adverse Events
Percentage of ParticipantsConcomitant RotaTeq and IPVStaggered RotaTeq and IPV
Elevated temperature12.316.3
Diarrhoea13.221.5
Vomiting10.619.5
SecondaryPercentage 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.

Time frame:
Up to approximately 3.5 months
Reported as:
Number · Percentage of Participants
Percentage of Participants With Serious Adverse Events (SAEs)
Percentage of ParticipantsConcomitant RotaTeq and IPVStaggered RotaTeq and IPV
Percentage of Participants With Serious Adverse Events (SAEs)3.75.5

Adverse events

Collected over Up to approximately 3.5 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Concomitant RotaTeq and IPV0/189 (0%)7/189 (3.7%)123/189 (65.1%)
Staggered RotaTeq and IPV0/200 (0%)11/200 (5.5%)143/200 (71.5%)
Most frequent serious events
Showing 10 of 11
Most frequent serious events
EventConcomitant RotaTeq and IPVStaggered RotaTeq and IPV
PneumoniaInfections and infestations3/1896/200
BronchitisInfections and infestations3/1890/200
Motor developmental delayNervous system disorders1/1890/200
EnteritisGastrointestinal disorders0/1891/200
EpididymitisInfections and infestations0/1891/200
Gastrointestinal viral infectionInfections and infestations0/1891/200
InfluenzaInfections and infestations0/1891/200
Septic shockInfections and infestations0/1891/200
Upper respiratory tract infectionInfections and infestations0/1891/200
Pneumonia aspirationInfections and infestations0/1891/200
Most frequent other events
Showing 10 of 12
Most frequent other events
EventConcomitant RotaTeq and IPVStaggered RotaTeq and IPV
DiarrhoeaGastrointestinal disorders33/18950/200
Injection site erythemaGeneral disorders45/18941/200
VomitingGastrointestinal disorders20/18939/200
PyrexiaGeneral disorders30/18937/200
Upper respiratory tract infectionInfections and infestations31/18936/200
CoughRespiratory, thoracic and mediastinal disorders19/18914/200
RhinorrhoeaRespiratory, thoracic and mediastinal disorders17/18918/200
EczemaSkin and subcutaneous tissue disorders14/18912/200
NasopharyngitisInfections and infestations14/18914/200
DyspepsiaGastrointestinal disorders10/18913/200

Baseline characteristics

Age, Continuous
Age, Continuous(days)Concomitant RotaTeq and IPVStaggered RotaTeq and IPVTotal
Mean53.3 ± 4.853.3 ± 4.653.3 ± 4.7
Age, Customized
Age, Customized(Participants)Concomitant RotaTeq and IPVStaggered RotaTeq and IPVTotal
Infants and toddlers (48 to 63 days)200200400
Sex: Female, Male
Sex: Female, Male(Participants)Concomitant RotaTeq and IPVStaggered RotaTeq and IPVTotal
Female8693179
Male114107221
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Concomitant RotaTeq and IPVStaggered RotaTeq and IPVTotal
Hispanic or Latino000
Not Hispanic or Latino200200400
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Concomitant RotaTeq and IPVStaggered RotaTeq and IPVTotal
American Indian or Alaska Native000
Asian200200400
Native Hawaiian or Other Pacific Islander000
Black or African American000
White000
More than one race000
Unknown or Not Reported000
07

Study locations

1 site
  • Yangchun Center For Disease Prevention And Control ( Site 0001)
    Yangchun, Guangdong 529600, China
08

References and documents

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 documents

  • Protocol and statistical analysis plan · Jun 1, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

09

Registry details

Key details

Study ID
NCT04481191
Lead sponsor
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
Jul 22, 2020
Start date
Aug 25, 2020
Primary completion
May 8, 2021
Completion
May 8, 2021
Results posted
Feb 17, 2023
Last update
Jul 26, 2024

Study contacts

Medical Director
study director · Merck Sharp & Dohme LLC

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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