Efficacy, Safety, and Immunogenicity of V260 in Healthy Chinese Infants (V260-024)

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• Gastroenteritis 243

Gastroenteritis

243 studies on the registry are indexed under Gastroenteritis; 15 are open to participants now.

This study's enrollment of 4,040 is above the median of 126 across 160 interventional studies indexed under Gastroenteritis.

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Study arms

• Experimental
  V260 with staggered EPI

  V260 administered as a 2 mL oral solution at age \~2, 3, and 4 months, and staggered China Expanded Program on Immunizations (EPI) as follows: Oral poliovirus vaccine (OPV) administered as a 1 g oral solution at age \~2.5, 3.5, and 4.5 months, and diphtheria, tetanus, acellular pertussis vaccine (DTaP) administered as a 0.5 mL intramuscular injection at age \~3.5, 4.5, and 5.5 months

  Biological: V260 · Biological: OPV · Biological: DTaP

• Placebo comparator
  Placebo with staggered EPI

  Placebo administered as a 2 mL oral solution at age \~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age \~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age \~3.5, 4.5, and 5.5 months

  Biological: Placebo to V260 · Biological: OPV · Biological: DTaP

• Experimental
  V260 with concomitant EPI

  V260 administered as a 2 mL oral solution at age \~2, 3, and 4 months, and concomitant EPI as follows: OPV administered as a 1 g oral solution at age \~2, 3, and 4 months and DTaP administered as a 0.5 mL intramuscular injection at age \~3, 4, and 5 months

  Biological: V260 · Biological: OPV · Biological: DTaP

• Placebo comparator
  Placebo with concomitant EPI

  Placebo administered as a 2 mL oral solution at age \~2, 3, and 4 months, and concomitant EPI as follows: OPV administered as a 1 g oral solution at age \~2, 3, and 4 months and DTaP administered as a 0.5 mL intramuscular injection at age \~3, 4, and 5 months

  Biological: Placebo to V260 · Biological: OPV · Biological: DTaP

Interventions

• BiologicalV260

  V260 (RotaTeq™; live, oral, pentavalent rotavirus vaccine)

• BiologicalPlacebo to V260

  Placebo control

• BiologicalOPV

  Oral poliovirus vaccine administered according to the standard of care

• BiologicalDTaP

  Diphtheria, Tetanus, Acellular Pertussis vaccine administered according to the standard of care

Primary outcomes

1. Number of Participants With Any Severity of Rotavirus Gastroenteritis

   The number of participants with rotavirus gastroenteritis (RVGE) caused by naturally-occurring wild-type rotavirus (regardless of serotype or disease severity) was assessed. The case definition of RVGE included 1) 3 or more watery or looser-than-normal stools within a 24-hour period and/or forceful vomiting, and 2) naturally-occurring wild-type rotavirus must be detected in a stool specimen taken within 7 days after the onset of symptoms.

   Time frame: From 14 days after the third dose of V260 or placebo through the first rotavirus season (up to 15 months)

Secondary outcomes

1. Percentage of Participants With Elevated Temperature

   Elevated temperature (temperature \>=37.5°C axillary or equivalent) was noted by the guardian and recorded on the Vaccination Report Card during Day 1 to Day 14 after each dose of vaccination. Elevated temperature reported by the guardian was also collected as an adverse event (pyrexia) during Day 15 to Day 30 after each dose of vaccination. The percentage of participants with axillary temperature \>=37.5 °C or an adverse event of pyrexia was assessed.

   Time frame: Up to 30 days after any dose of V260 or Placebo

2. Percentage of Participants With Vomiting or Diarrhea

   Episodes of vomiting and diarrhea were noted by the guardian and recorded on the Vaccination Record Card during Day 1 to Day 14 after each dose of vaccination. Vomiting and diarrhea reported by the guardian were also collected as an adverse event during Day 15 to Day 30 after any dose of vaccination. The percentage of participants with an episode or an adverse event of vomiting or diarrhea was assessed.

   Time frame: Up to 30 days after any dose of V260 or Placebo

3. Percentage of Participants With Intussusception

   Episodes of intussusception were collected from the time of written consent until the end of study. The percentage of participants with an episode of intussusception was assessed.

   Time frame: Up to 15 months

4. Number of Participants With Severe Rotavirus Gastroenteritis

   The number of participants with severe rotavirus gastroenteritis (RVGE) caused by naturally-occurring wild-type rotavirus (regardless of serotype or disease severity) was assessed. The case definition of RVGE included 1) 3 or more watery or looser-than-normal stools within a 24-hour period and/or forceful vomiting, and 2) naturally-occurring wild-type rotavirus must be detected in a stool specimen taken within 7 days after the onset of symptoms. Severe RVGE was defined as \>=11 on the Vesikari Scoring System, a composite of the seven parameters related to symptoms and treatment with an overall range from 0 to 20.

   Time frame: From 14 days after the third dose of V260 or placebo through the first rotavirus season (up to 15 months)

5. Percentage of Participants Who Achieved Seroprotection Against Poliovirus Type 1, 2, or 3

   The percentage of participants who achieved seroprotection against poliovirus Type 1, 2, or 3 was assessed. Seroprotection was defined as a neutralizing antibody titer \>=1:8. This outcome was evaluated only in participants receiving concomitant administration of V260 and OPV.

   Time frame: Baseline and between 28 and 56 days after the third OPV vaccination

6. Percentage of Participants With Any Adverse Event

   An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the sponsor's product, is also an adverse event.

   Time frame: Up to 30 days after any dose of V260 or Placebo

7. Percentage of Participants Seropositive to Diphtheria, Pertussis, or Tetanus Antigens

   The percentage of participants seropositive to diphtheria, pertussis, or tetanus antigens was assessed. Seropositive was defined as the following: 1) anti-diphtheria antibody titers \>=0.1 International Units (IU)/mL, 2) anti-tetanus antibody titers \>=0.1 IU/mL, 3) antipertussis toxin antibody titers \>=20 Enzyme-linked Immunosorbent Assay (ELISA) Units (EU)/mL, 4) anti-pertussis filamentous hemagglutinin (FHA) antibody titers \>=20 EU/mL. This outcome was evaluated only in participants receiving concomitant administration of V260 and EPI.

   Time frame: Baseline and between 28 and 51 days after the third DTaP vaccination

Baseline characteristics

Publications

• Mo Z, Mo Y, Li M, Tao J, Yang X, Kong J, Wei D, Fu B, Liao X, Chu J, Qiu Y, Hille DA, Nelson M, Kaplan SS. Efficacy and safety of a pentavalent live human-bovine reassortant rotavirus vaccine (RV5) in healthy Chinese infants: A randomized, double-blind, placebo-controlled trial. Vaccine. 2017 Oct 13;35(43):5897-5904. doi: 10.1016/j.vaccine.2017.08.081. Epub 2017 Sep 19. PubMed 28935470 ↗
• Mo Z, Ma X, Luo P, Mo Y, Kaplan SS, Shou Q, Zheng M, Hille DA, Arnold BA; V260-024 Study Group; Liao X. Immunogenicity of pentavalent rotavirus vaccine in Chinese infants. Vaccine. 2019 Mar 22;37(13):1836-1843. doi: 10.1016/j.vaccine.2019.02.018. Epub 2019 Feb 23. PubMed 30808567 ↗

Individual participant data

Plan to share: Yes — https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf