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This study will assess the efficacy, safety, and immunogenicity of a 3-dose regimen of RotaTeq™ (V260) in healthy Chinese infants. Approximately 4040 participants at least 6 weeks and up to 12 weeks of age at the time of the first vaccination with V260 or placebo will be enrolled and randomized (1:1) to receive either V260 or placebo. Participants will also receive the routine China Expanded Program on Immunization (EPI) vaccines (oral poliovirus vaccine [OPV] and diphtheria, tetanus, and acellular pertussis vaccine [DTaP]) either staggered or concomitantly with V260 or placebo. All participants will be followed for efficacy and safety. Immune responses to OPV and DTaP will be evaluated in a subset of participants. The primary hypothesis of the study states that V260 will be efficacious in preventing any severity of rotavirus gastroenteritis as compared with placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| V260 with staggered EPI | Experimental | 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 |
|
| Placebo with staggered EPI | Placebo Comparator | 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 |
|
| V260 with concomitant EPI | Experimental | 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 |
|
| Placebo with concomitant EPI | Placebo Comparator | 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V260 | Biological | V260 (RotaTeq™; live, oral, pentavalent rotavirus vaccine) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From 14 days after the third dose of V260 or placebo through the first rotavirus season (up to 15 months) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28935470 | Result | 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. | |
| 30808567 |
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A total of 4173 participants were screened, 4040 were randomized, and 4037 received at least one dose of study vaccination.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 Immunization (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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All randomized participants
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| ID | Title | Description |
|---|---|---|
| BG000 | V260 With Staggered EPI | V260 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Participants who were vaccinated in either the staggered EPI or concomitant EPI groups, were not protocol violators, and were classified as evaluable for RVGE according to the per-protocol case definition. | Posted | Number | Participants | From 14 days after the third dose of V260 or placebo through the first rotavirus season (up to 15 months) |
|
All Adverse Events: up to 30 days after any V260 or placebo vaccination; Serious Adverse Events: from the time of written consent until the end of the study (up to 15 months)
The at-risk population was All Subjects as Treated
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | V260 With Staggered or Concomitant EPI | V260 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 OR 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Agranulocytosis | Blood and lymphatic system disorders | MedDRA version 18 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA version 18 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D022243 | Rotavirus Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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|
| Placebo to V260 | Biological | Placebo control |
|
| OPV | Biological | Oral poliovirus vaccine administered according to the standard of care |
|
| DTaP | Biological | Diphtheria, Tetanus, Acellular Pertussis vaccine administered according to the standard of care |
|
| Up to 30 days after any dose of V260 or Placebo |
| 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. | Up to 30 days after any dose of V260 or Placebo |
| 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. | Up to 15 months |
| 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. | From 14 days after the third dose of V260 or placebo through the first rotavirus season (up to 15 months) |
| 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. | Baseline and between 28 and 56 days after the third OPV vaccination |
| 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. | Up to 30 days after any dose of V260 or Placebo |
| 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. | Baseline and between 28 and 51 days after the third DTaP vaccination |
| 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. |
| Protocol Violation |
|
| Incomplete EPI by database lock |
|
| Moved |
|
| Withdrawn by parent/guardian |
|
| Death |
|
| Lost to Follow-up |
|
| 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Days |
|
| Sex: Female, Male | Count of Participants | Participants |
|
V260 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 OR 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.
| OG001 | Placebo With Staggered or Concomitant 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 OR 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. |
|
|
|
| Secondary | 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. | All Subjects as Treated with follow-up specific to the endpoint | Posted | Number | Percentage of participants | Up to 30 days after any dose of V260 or Placebo |
|
|
|
| Secondary | 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. | All Subjects as Treated with safety follow-up | Posted | Number | Percentage of participants | Up to 30 days after any dose of V260 or Placebo |
|
|
|
| Secondary | 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. | All Subjects as Treated with safety follow-up | Posted | Number | Percentage of participants | Up to 15 months |
|
|
|
| Secondary | 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. | Participants who were vaccinated in either the staggered EPI or concomitant EPI groups, were not protocol violators, and were classified as evaluable for RVGE according to the per-protocol case definition. | Posted | Number | Participants | From 14 days after the third dose of V260 or placebo through the first rotavirus season (up to 15 months) |
|
|
|
| Secondary | 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. | Participants in the concomitant EPI groups who receive their scheduled doses of OPV without intervening disease specific to the antigen before the blood sample collection postdose 3, adhere to the guidelines for administration of vaccine, and have valid values available for analysis within specified day ranges. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline and between 28 and 56 days after the third OPV vaccination |
|
|
|
| Secondary | 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. | All Subjects as Treated with safety follow-up | Posted | Number | Percentage of participants | Up to 30 days after any dose of V260 or Placebo |
|
|
|
| Secondary | 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. | Participants in the concomitant EPI groups who receive their scheduled doses of DTaP without intervening disease specific to the antigen before the blood sample collection postdose 3, adhere to the guidelines for administration of vaccine, and have valid values available for analysis within specified day ranges. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline and between 28 and 51 days after the third DTaP vaccination |
|
|
|
| 339 |
| 2,015 |
| 938 |
| 2,015 |
| EG001 | Placebo With Staggered or Concomitant 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 OR 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. | 338 | 2,019 | 931 | 2,019 |
| Anaemia | Blood and lymphatic system disorders | MedDRA version 18 | Systematic Assessment |
|
| Granulocytopenia | Blood and lymphatic system disorders | MedDRA version 18 | Systematic Assessment |
|
| Cardiomyopathy | Cardiac disorders | MedDRA version 18 | Systematic Assessment |
|
| Developmental hip dysplasia | Congenital, familial and genetic disorders | MedDRA version 18 | Systematic Assessment |
|
| Talipes | Congenital, familial and genetic disorders | MedDRA version 18 | Systematic Assessment |
|
| Thalassaemia | Congenital, familial and genetic disorders | MedDRA version 18 | Systematic Assessment |
|
| Thalassaemia beta | Congenital, familial and genetic disorders | MedDRA version 18 | Systematic Assessment |
|
| Ventricular septal defect | Congenital, familial and genetic disorders | MedDRA version 18 | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA version 18 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA version 18 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA version 18 | Systematic Assessment |
|
| Enteritis | Gastrointestinal disorders | MedDRA version 18 | Systematic Assessment |
|
| Functional gastrointestinal disorder | Gastrointestinal disorders | MedDRA version 18 | Systematic Assessment |
|
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA version 18 | Systematic Assessment |
|
| Incarcerated inguinal hernia | Gastrointestinal disorders | MedDRA version 18 | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA version 18 | Systematic Assessment |
|
| Intussusception | Gastrointestinal disorders | MedDRA version 18 | Systematic Assessment |
|
| Developmental delay | General disorders | MedDRA version 18 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA version 18 | Systematic Assessment |
|
| Transient hypogammaglobulinaemia of infancy | Immune system disorders | MedDRA version 18 | Systematic Assessment |
|
| Acute tonsillitis | Infections and infestations | MedDRA version 18 | Systematic Assessment |
|
| Bronchiolitis | Infections and infestations | MedDRA version 18 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA version 18 | Systematic Assessment |
|
| Bronchopneumonia | Infections and infestations | MedDRA version 18 | Systematic Assessment |
|
| Candida infection | Infections and infestations | MedDRA version 18 | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA version 18 | Systematic Assessment |
|
| Cytomegalovirus infection | Infections and infestations | MedDRA version 18 | Systematic Assessment |
|
| Diarrhoea infectious | Infections and infestations | MedDRA version 18 | Systematic Assessment |
|
| Exanthema subitum | Infections and infestations | MedDRA version 18 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA version 18 | Systematic Assessment |
|
| Gastroenteritis adenovirus | Infections and infestations | MedDRA version 18 | Systematic Assessment |
|
| Gastroenteritis bacterial | Infections and infestations | MedDRA version 18 | Systematic Assessment |
|
| Gastroenteritis rotavirus | Infections and infestations | MedDRA version 18 | Systematic Assessment |
|
| Gastroenteritis shigella | Infections and infestations | MedDRA version 18 | Systematic Assessment |
|
| Gingivitis | Infections and infestations | MedDRA version 18 | Systematic Assessment |
|
| Hand-foot-and-mouth disease | Infections and infestations | MedDRA version 18 | Systematic Assessment |
|
| Herpangina | Infections and infestations | MedDRA version 18 | Systematic Assessment |
|
| Herpes virus infection | Infections and infestations | MedDRA version 18 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA version 18 | Systematic Assessment |
|
| Omphalitis | Infections and infestations | MedDRA version 18 | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA version 18 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA version 18 | Systematic Assessment |
|
| Oral infection | Infections and infestations | MedDRA version 18 | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA version 18 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA version 18 | Systematic Assessment |
|
| Pharyngitis bacterial | Infections and infestations | MedDRA version 18 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA version 18 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA version 18 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA version 18 | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA version 18 | Systematic Assessment |
|
| Tonsillitis bacterial | Infections and infestations | MedDRA version 18 | Systematic Assessment |
|
| Toxoplasmosis | Infections and infestations | MedDRA version 18 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA version 18 | Systematic Assessment |
|
| Burns second degree | Injury, poisoning and procedural complications | MedDRA version 18 | Systematic Assessment |
|
| Eye contusion | Injury, poisoning and procedural complications | MedDRA version 18 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA version 18 | Systematic Assessment |
|
| Malnutrition | Metabolism and nutrition disorders | MedDRA version 18 | Systematic Assessment |
|
| Rickets | Musculoskeletal and connective tissue disorders | MedDRA version 18 | Systematic Assessment |
|
| Central nervous system lesion | Nervous system disorders | MedDRA version 18 | Systematic Assessment |
|
| Epilepsy | Nervous system disorders | MedDRA version 18 | Systematic Assessment |
|
| Febrile convulsion | Nervous system disorders | MedDRA version 18 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA version 18 | Systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA version 18 | Systematic Assessment |
|
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA version 18 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA version 18 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA version 18 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA version 18 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA version 18 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 18 | Systematic Assessment |
|
The sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results.
| Poliovirus Type 2: Baseline, n=186, 190 |
|
| Poliovirus Type 2: Post OPV #3, n=187, 192 |
|
| Poliovirus Type 3: Baseline, n=186, 190 |
|
| Poliovirus Type 3: Post OPV #3, n=187, 192 |
|
| Pertussis FHA: Baseline, n=181, 186 |
|
| Pertussis FHA: Post DTaP #3, n=187, 194 |
|
| Pertussis Toxin: Baseline, n=181, 186 |
|
| Pertussis Toxin, Post DTaP #3, n=187, 194 |
|
| Tetanus: Baseline, n=181, 186 |
|
| Tetanus: Post DTaP #3, n=187, 194 |
|