Trial Outcomes & Findings for Coadministration of Measles-rubella and Rotavirus Vaccines (NCT NCT01700621)

Results Overview

Detected by plaque reduction neutralization test (PRNT). Seroprotection defined as measles serum antibody concentration \>=1:120 8 weeks post vaccination. Assays were standardized using WHO Second International Standard for measles antibody containing 5000 mIU/ml, which enables the 50% neutralizing antibody end-point dose (titer, ND50) of test samples to be transformed to antibody concentrations in terms of mIU/ml. The analytical cut-off value in this assay was ND50 \< 1/8; this was the lowest dilution at which sera were tested.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

482 participants

Primary outcome timeframe

8 weeks post vaccination

Results posted on

2019-03-13

Participant Flow

Study population was drawn from participants living in the International Center for Diarrheal Disease Research, Bangladesh (icddr,b) service area of Matlab, Bangladesh.

Recruitment concurrently conducted at a number of health sites in the study area, which resulted in two additional infants being enrolled but subsequently not vaccinated with withdrawn from the study.

Participant milestones

Participant milestones
Measure	Measles-rubella and Rotavirus Vaccines receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine and one 1.0 ml dose of oral Rotarix vaccine at 9 months of age Rotarix vaccine: one 1.0 ml dose of oral rotavirus vaccine at 9 months of age measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine	Measles-rubella Vaccine receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine at 9 months of age measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine
Received Study Vaccines STARTED	240	240
Received Study Vaccines COMPLETED	240	240
Received Study Vaccines NOT COMPLETED	0	0
Analyzed for Immunogenicity STARTED	240	240
Analyzed for Immunogenicity COMPLETED	227	233
Analyzed for Immunogenicity NOT COMPLETED	13	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Measles-rubella and Rotavirus Vaccines receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine and one 1.0 ml dose of oral Rotarix vaccine at 9 months of age Rotarix vaccine: one 1.0 ml dose of oral rotavirus vaccine at 9 months of age measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine	Measles-rubella Vaccine receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine at 9 months of age measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine
Analyzed for Immunogenicity Lost to Follow-up	7	4
Analyzed for Immunogenicity Protocol Violation	5	1
Analyzed for Immunogenicity Baseline measles measure high	1	2

Baseline Characteristics

Coadministration of Measles-rubella and Rotavirus Vaccines

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Measles-rubella and Rotavirus Vaccines n=240 Participants receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine and one 1.0 ml dose of oral Rotarix vaccine at 9 months of age Rotarix vaccine: one 1.0 ml dose of oral rotavirus vaccine at 9 months of age measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine	Measles-rubella Vaccine n=240 Participants receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine at 9 months of age measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine	Total n=480 Participants Total of all reporting groups
Age, Continuous	9.38 months STANDARD_DEVIATION 0.252 • n=5 Participants	9.39 months STANDARD_DEVIATION 0.254 • n=7 Participants	9.38 months STANDARD_DEVIATION 0.253 • n=5 Participants
Sex: Female, Male Female	110 Participants n=5 Participants	123 Participants n=7 Participants	233 Participants n=5 Participants
Sex: Female, Male Male	130 Participants n=5 Participants	117 Participants n=7 Participants	247 Participants n=5 Participants
Currently breastfed Yes	236 Participants n=5 Participants	238 Participants n=7 Participants	474 Participants n=5 Participants
Currently breastfed No	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Length	69.56 cm STANDARD_DEVIATION 2.488 • n=5 Participants	69.81 cm STANDARD_DEVIATION 2.786 • n=7 Participants	69.68 cm STANDARD_DEVIATION 2.642 • n=5 Participants
Weight	8.01 kilograms STANDARD_DEVIATION 1.101 • n=5 Participants	7.97 kilograms STANDARD_DEVIATION 0.933 • n=7 Participants	7.99 kilograms STANDARD_DEVIATION 1.047 • n=5 Participants
Mother's age	27.1 years STANDARD_DEVIATION 5.84 • n=5 Participants	26.7 years STANDARD_DEVIATION 5.90 • n=7 Participants	26.9 years STANDARD_DEVIATION 5.87 • n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks post vaccination

Detected by plaque reduction neutralization test (PRNT). Seroprotection defined as measles serum antibody concentration \>=1:120 8 weeks post vaccination. Assays were standardized using WHO Second International Standard for measles antibody containing 5000 mIU/ml, which enables the 50% neutralizing antibody end-point dose (titer, ND50) of test samples to be transformed to antibody concentrations in terms of mIU/ml. The analytical cut-off value in this assay was ND50 \< 1/8; this was the lowest dilution at which sera were tested.

Outcome measures

Outcome measures
Measure	Measles-rubella and Rotavirus Vaccines n=227 Participants receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine and one 1.0 ml dose of oral Rotarix vaccine at 9 months of age Rotarix vaccine: one 1.0 ml dose of oral rotavirus vaccine at 9 months of age measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine	Measles-rubella Vaccine n=233 Participants receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine at 9 months of age measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine
Percentage/Number of Subjects With Seroprotection for Measles Virus Serum Neutralization Antibodies Seroprotection	171 Participants	173 Participants
Percentage/Number of Subjects With Seroprotection for Measles Virus Serum Neutralization Antibodies No seroprotection	56 Participants	60 Participants

PRIMARY outcome

Timeframe: 8 weeks post vaccination

Population: All children meeting inclusion/exclusion criteria with a valid sample.

Used commercially available indirect enzyme-linked IgG immunoassays (EIAs; Wampole Laboratories, Princeton, New Jersey). An index standard ratio (ISR) of ≥1.10 on both runs of the respective assay was considered evidence of seropositivity for measles virus. All measles virus and rubella virus assays were performed at the National Measles and Rubella Reference Laboratories, Measles, Mumps, Rubella, and Herpesviruses Branch, Division of Viral Diseases, Centers for Disease Control and Prevention (Atlanta, Georgia).

Outcome measures

Outcome measures
Measure	Measles-rubella and Rotavirus Vaccines n=227 Participants receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine and one 1.0 ml dose of oral Rotarix vaccine at 9 months of age Rotarix vaccine: one 1.0 ml dose of oral rotavirus vaccine at 9 months of age measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine	Measles-rubella Vaccine n=232 Participants receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine at 9 months of age measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine
Percentage/Number of Subjects With Seroprotection for Anti-measles Virus Immunoglobulin G (IgG) Seroprotection	219 Participants	227 Participants
Percentage/Number of Subjects With Seroprotection for Anti-measles Virus Immunoglobulin G (IgG) No seroprotection	8 Participants	5 Participants

SECONDARY outcome

Timeframe: 8 weeks post vaccination

Population: All children meeting inclusion and exclusion criteria with valid samples.

Used commercially available indirect enzyme-linked IgG immunoassays (EIAs; Wampole Laboratories, Princeton, New Jersey). An index standard ratio (ISR) of ≥1.10 on both runs of the respective assay was considered evidence of seropositivity for rubella virus. An ISR of at least 1.10 represents 10 IU/mL of rubella virus antibody, consistent with a protective level.All measles virus and rubella virus assays were performed at the National Measles and Rubella Reference Laboratories, Measles, Mumps, Rubella, and Herpesviruses Branch, Division of Viral Diseases, Centers for Disease Control and Prevention (Atlanta, Georgia).

Outcome measures

Outcome measures
Measure	Measles-rubella and Rotavirus Vaccines n=228 Participants receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine and one 1.0 ml dose of oral Rotarix vaccine at 9 months of age Rotarix vaccine: one 1.0 ml dose of oral rotavirus vaccine at 9 months of age measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine	Measles-rubella Vaccine n=234 Participants receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine at 9 months of age measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine
Percentage/Number of Subjects With Seroconversion for Anti-rubella Virus Immunoglobulin G (IgG) Seroprotection	228 Participants	233 Participants
Percentage/Number of Subjects With Seroconversion for Anti-rubella Virus Immunoglobulin G (IgG) No seroprotection	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 8 weeks post vaccination

Used commercially available indirect enzyme-linked IgG immunoassays (EIAs; Wampole Laboratories, Princeton, New Jersey). An index standard ratio (ISR) of ≥1.10 on both runs of the respective assay was considered evidence of seropositivity for rubella virus. An ISR of at least 1.10 represents 10 IU/mL of rubella virus antibody, consistent with a protective level.All measles virus and rubella virus assays were performed at the National Measles and Rubella Reference Laboratories, Measles, Mumps, Rubella, and Herpesviruses Branch, Division of Viral Diseases, Centers for Disease Control and Prevention (Atlanta, Georgia).

Outcome measures

Outcome measures
Measure	Measles-rubella and Rotavirus Vaccines n=228 Participants receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine and one 1.0 ml dose of oral Rotarix vaccine at 9 months of age Rotarix vaccine: one 1.0 ml dose of oral rotavirus vaccine at 9 months of age measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine	Measles-rubella Vaccine n=234 Participants receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine at 9 months of age measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine
Geometric Mean Concentration (GMC) for Anti-rubella Virus Immunoglobulin G (IgG)	191.9 IU/mL Interval 174.8 to 210.7	177.8 IU/mL Interval 161.8 to 195.4

SECONDARY outcome

Timeframe: Visit 1 (pre-vaccination) and 8 weeks post vaccination

Population: All participants meeting inclusion/exclusion criteria and with valid samples.

Antirotavirus immunoglobulin A (IgA) and IgG were measured by enzyme-linked immunosorbent assay at the Laboratory of Specialized Clinical Studies at the Cincinnati Children's Hospital Medical Center (Cincinnati, Ohio). A standard serum pool was used to determine arbitrary units of rotavirus IgA or IgG in each sample. A subject was considered seropositive if the IgA or IgG rotavirus antibody concentration was ≥20 U/mL.

Outcome measures

Outcome measures
Measure	Measles-rubella and Rotavirus Vaccines n=239 Participants receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine and one 1.0 ml dose of oral Rotarix vaccine at 9 months of age Rotarix vaccine: one 1.0 ml dose of oral rotavirus vaccine at 9 months of age measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine	Measles-rubella Vaccine n=240 Participants receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine at 9 months of age measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine
Percentage/Number of Subjects Seropositive for Anti-rotavirus Immunoglobulin A (IgA) Pre-vaccination · Seropositive	126 Participants	113 Participants
Percentage/Number of Subjects Seropositive for Anti-rotavirus Immunoglobulin A (IgA) Pre-vaccination · Not seropositive	113 Participants	127 Participants
Percentage/Number of Subjects Seropositive for Anti-rotavirus Immunoglobulin A (IgA) Post-vaccination · Seropositive	160 Participants	110 Participants
Percentage/Number of Subjects Seropositive for Anti-rotavirus Immunoglobulin A (IgA) Post-vaccination · Not seropositive	70 Participants	130 Participants

SECONDARY outcome

Timeframe: Visit 1 (pre-vaccination) and 8 weeks post vaccination

Population: All participants meeting inclusion/exclusion criteria and with valid samples.

Antirotavirus immunoglobulin A (IgA) and IgG were measured by enzyme-linked immunosorbent assay at the Laboratory of Specialized Clinical Studies at the Cincinnati Children's Hospital Medical Center (Cincinnati, Ohio). A standard serum pool was used to determine arbitrary units of rotavirus IgA or IgG in each sample. Rotavirus IgA and IgG values of \<20 U/mL are converted to 10 U/mL for calculation purposes.

Outcome measures

Outcome measures
Measure	Measles-rubella and Rotavirus Vaccines n=239 Participants receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine and one 1.0 ml dose of oral Rotarix vaccine at 9 months of age Rotarix vaccine: one 1.0 ml dose of oral rotavirus vaccine at 9 months of age measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine	Measles-rubella Vaccine n=240 Participants receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine at 9 months of age measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine
Geometric Mean Titer (GMT) of Anti-rotavirus Immunoglobulin A (IgA) Pre-vaccination	43.6 U/mL Interval 34.8 to 54.5	39.2 U/mL Interval 31.3 to 49.1
Geometric Mean Titer (GMT) of Anti-rotavirus Immunoglobulin A (IgA) Post-vaccination	60.6 U/mL Interval 49.4 to 74.2	38.1 U/mL Interval 30.5 to 47.6

SECONDARY outcome

Timeframe: Visit 1 (pre-vaccination) and 8 weeks post vaccination

Population: All participants meeting inclusion/exclusion criteria and with valid samples.

Antirotavirus immunoglobulin A (IgA) and IgG were measured by enzyme-linked immunosorbent assay at the Laboratory of Specialized Clinical Studies at the Cincinnati Children's Hospital Medical Center (Cincinnati, Ohio). A standard serum pool was used to determine arbitrary units of rotavirus IgA or IgG in each sample. A subject was considered seropositive if the IgA or IgG rotavirus antibody concentration was ≥20 U/mL.

Outcome measures

Outcome measures
Measure	Measles-rubella and Rotavirus Vaccines n=240 Participants receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine and one 1.0 ml dose of oral Rotarix vaccine at 9 months of age Rotarix vaccine: one 1.0 ml dose of oral rotavirus vaccine at 9 months of age measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine	Measles-rubella Vaccine n=240 Participants receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine at 9 months of age measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine
Percentage/Number of Subjects Seropositive for Anti-rotavirus Immunoglobulin G (IgG) Pre-vaccination · Seropositive	159 Participants	140 Participants
Percentage/Number of Subjects Seropositive for Anti-rotavirus Immunoglobulin G (IgG) Pre-vaccination · Not seropositive	81 Participants	100 Participants
Percentage/Number of Subjects Seropositive for Anti-rotavirus Immunoglobulin G (IgG) Post-vaccination · Seropositive	204 Participants	135 Participants
Percentage/Number of Subjects Seropositive for Anti-rotavirus Immunoglobulin G (IgG) Post-vaccination · Not seropositive	27 Participants	101 Participants

SECONDARY outcome

Timeframe: Visit 1 (pre-vaccination) and 8 weeks post vaccination

Population: All participants meeting inclusion/exclusion criteria and with valid samples.

Antirotavirus immunoglobulin A (IgA) and IgG were measured by enzyme-linked immunosorbent assay at the Laboratory of Specialized Clinical Studies at the Cincinnati Children's Hospital Medical Center (Cincinnati, Ohio). A standard serum pool was used to determine arbitrary units of rotavirus IgA or IgG in each sample. Rotavirus IgA and IgG values of \<20 U/mL are converted to 10 U/mL for calculation purposes.

Outcome measures

Outcome measures
Measure	Measles-rubella and Rotavirus Vaccines n=240 Participants receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine and one 1.0 ml dose of oral Rotarix vaccine at 9 months of age Rotarix vaccine: one 1.0 ml dose of oral rotavirus vaccine at 9 months of age measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine	Measles-rubella Vaccine n=240 Participants receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine at 9 months of age measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine
Geometric Mean Titer (GMT) of Anti-rotavirus Immunoglobulin G (IgG) Pre-vaccination	79.2 U/mL Interval 61.4 to 102.1	63.2 U/mL Interval 49.1 to 81.4
Geometric Mean Titer (GMT) of Anti-rotavirus Immunoglobulin G (IgG) Post-vaccination	168.6 U/mL Interval 137.3 to 207.2	60.1 U/mL Interval 46.7 to 77.5

SECONDARY outcome

Timeframe: 8 weeks post vaccination

Population: All subjects that met inclusion and exclusion criteria with valid samples and were not seropositive prior to the intervention

Antirotavirus immunoglobulin A (IgA) and IgG were measured by enzyme-linked immunosorbent assay at the Laboratory of Specialized Clinical Studies at the Cincinnati Children's Hospital Medical Center (Cincinnati, Ohio). A standard serum pool was used to determine arbitrary units of rotavirus IgA or IgG in each sample. A subject was considered seropositive if the IgA or IgG rotavirus antibody concentration was ≥20 U/mL.

Outcome measures

Outcome measures
Measure	Measles-rubella and Rotavirus Vaccines n=110 Participants receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine and one 1.0 ml dose of oral Rotarix vaccine at 9 months of age Rotarix vaccine: one 1.0 ml dose of oral rotavirus vaccine at 9 months of age measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine	Measles-rubella Vaccine n=126 Participants receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine at 9 months of age measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine
Percentage/Number of Subjects With Seroconversion for Anti-rotavirus Immunoglobulin A (IgA) Seroconversion	48 Participants	8 Participants
Percentage/Number of Subjects With Seroconversion for Anti-rotavirus Immunoglobulin A (IgA) No seroconversion	62 Participants	118 Participants

SECONDARY outcome

Timeframe: 8 weeks post vaccination

Antirotavirus immunoglobulin A (IgA) and IgG were measured by enzyme-linked immunosorbent assay at the Laboratory of Specialized Clinical Studies at the Cincinnati Children's Hospital Medical Center (Cincinnati, Ohio). A standard serum pool was used to determine arbitrary units of rotavirus IgA or IgG in each sample. A subject was considered seropositive if the IgA or IgG rotavirus antibody concentration was ≥20 U/mL.

Outcome measures

Outcome measures
Measure	Measles-rubella and Rotavirus Vaccines n=80 Participants receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine and one 1.0 ml dose of oral Rotarix vaccine at 9 months of age Rotarix vaccine: one 1.0 ml dose of oral rotavirus vaccine at 9 months of age measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine	Measles-rubella Vaccine n=99 Participants receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine at 9 months of age measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine
Percentage/Number of Subjects With Seroconversion for Anti-rotavirus Immunoglobulin G (IgG) Seroconversion	55 Participants	7 Participants
Percentage/Number of Subjects With Seroconversion for Anti-rotavirus Immunoglobulin G (IgG) No seroconversion	25 Participants	92 Participants

SECONDARY outcome

Timeframe: 30 minutes post-vaccination

Immediate reactogenicity was defined as local or systemic reactions occurring directly and up to 30 minutes after vaccine receipt, with an emphasis on allergic reactions.

Outcome measures

Outcome measures
Measure	Measles-rubella and Rotavirus Vaccines n=240 Participants receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine and one 1.0 ml dose of oral Rotarix vaccine at 9 months of age Rotarix vaccine: one 1.0 ml dose of oral rotavirus vaccine at 9 months of age measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine	Measles-rubella Vaccine n=240 Participants receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine at 9 months of age measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine
Number/Percentage of Subjects Experiencing Immediate Post-vaccination Reactions Following Administration of Vaccine Any immediate reaction	0 Participants	0 Participants
Number/Percentage of Subjects Experiencing Immediate Post-vaccination Reactions Following Administration of Vaccine No immediate reaction	240 Participants	240 Participants

SECONDARY outcome

Timeframe: 14 days post-vaccination

Solicited non-serious adverse events were collected based on recall at study visits 2 (Day 4) through 5 (Day 14) following administration of Rotarix® vaccine. They included diarrhea, fever, vomiting, loss of appetite, irritability, and intussusception. Adverse events were graded for severity and relationship to vaccine.

Outcome measures

Outcome measures
Measure	Measles-rubella and Rotavirus Vaccines n=240 Participants receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine and one 1.0 ml dose of oral Rotarix vaccine at 9 months of age Rotarix vaccine: one 1.0 ml dose of oral rotavirus vaccine at 9 months of age measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine	Measles-rubella Vaccine n=240 Participants receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine at 9 months of age measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine
Number/Percentage of Subjects Experiencing Solicited Adverse Events Grade 2: unrelated to vaccine	4 Participants	4 Participants
Number/Percentage of Subjects Experiencing Solicited Adverse Events Grade 1: unrelated to vaccine	25 Participants	34 Participants
Number/Percentage of Subjects Experiencing Solicited Adverse Events Grade 3: unrelated to vaccine	2 Participants	0 Participants
Number/Percentage of Subjects Experiencing Solicited Adverse Events None	209 Participants	202 Participants

SECONDARY outcome

Timeframe: 14 days post-vaccination

Solicited non-serious adverse events were collected based on recall at study visits 2 (Day 4) through 5 (Day 14) following administration of Rotarix® vaccine. Adverse events were graded for severity and relationship to vaccine.

Outcome measures

Outcome measures
Measure	Measles-rubella and Rotavirus Vaccines n=240 Participants receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine and one 1.0 ml dose of oral Rotarix vaccine at 9 months of age Rotarix vaccine: one 1.0 ml dose of oral rotavirus vaccine at 9 months of age measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine	Measles-rubella Vaccine n=240 Participants receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine at 9 months of age measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine
Number/Percentage of Subjects Experiencing Unsolicited Non-serious Adverse Events Related to vaccine	0 Participants	0 Participants
Number/Percentage of Subjects Experiencing Unsolicited Non-serious Adverse Events Unrelated to vaccine	63 Participants	68 Participants
Number/Percentage of Subjects Experiencing Unsolicited Non-serious Adverse Events No unsolicited non-serious adverse event	177 Participants	172 Participants

SECONDARY outcome

Timeframe: 2 months after vaccination

An adverse event (AE) or suspected AE was considered "serious" if it resulted in any of the following outcomes: * Death * A life-threatening AE (the term "life-threatening" in the definition of "serious" refers to an event in which the patient was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe) * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions Important medical events that may not result in death, be life threatening, or require hospitalization would have been considered severe adverse events when, based upon appropriate medical judgment, they may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes listed in this definition.

Outcome measures

Outcome measures
Measure	Measles-rubella and Rotavirus Vaccines n=240 Participants receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine and one 1.0 ml dose of oral Rotarix vaccine at 9 months of age Rotarix vaccine: one 1.0 ml dose of oral rotavirus vaccine at 9 months of age measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine	Measles-rubella Vaccine n=240 Participants receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine at 9 months of age measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine
Number/Percentage of Subjects Experiencing Serious Adverse Events Any serious adverse event, unrelated to vaccine	10 Participants	6 Participants
Number/Percentage of Subjects Experiencing Serious Adverse Events No serious adverse event	230 Participants	234 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 8 weeks post vaccination

Sera were analyzed for the presence of measles virus serum neutralizing antibodies (SNAs), using a standardized plaque reduction neutralization (PRN) assay, in which PRN titers, defined as the serum dilutions that reduced the number of plaques by 50%, were calculated using the Kärber method \[12\]. A 1:100 dilution of World Health Organization (WHO) Second International Standard Anti-Measles Serum (IS, coded 66/202, supplied by the National Institute for Biological Standards and Control, South Mimms, United Kingdom) was tested in parallel with each serum specimen to calculate the reciprocal of the 50% end point titer determined by the PRN test.

Outcome measures

Outcome measures
Measure	Measles-rubella and Rotavirus Vaccines n=227 Participants receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine and one 1.0 ml dose of oral Rotarix vaccine at 9 months of age Rotarix vaccine: one 1.0 ml dose of oral rotavirus vaccine at 9 months of age measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine	Measles-rubella Vaccine n=233 Participants receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine at 9 months of age measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine
Geometric Mean Concentration (GMC) for Measles Virus Serum Neutralization Antibodies	196.3 mIU/mL Interval 175.3 to 219.7	194.2 mIU/mL Interval 174.0 to 216.7

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0, Day 4 and Day 7

Based on 5 grams of stool sample. Vaccine shedding defined as presence of vaccine-type rotavirus in stool at 4 (+/-1) and/or 7 (+/-1) days post rotavirus vaccination detected by enzyme-linked immunosorbent assay (ELISA) and typed by reverse-transcriptase polymerase chain reaction (RT-PCR).

Outcome measures

Outcome measures
Measure	Measles-rubella and Rotavirus Vaccines n=240 Participants receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine and one 1.0 ml dose of oral Rotarix vaccine at 9 months of age Rotarix vaccine: one 1.0 ml dose of oral rotavirus vaccine at 9 months of age measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine	Measles-rubella Vaccine receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine at 9 months of age measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine
Number of Participants With Rotavirus Vaccine Shedding Day 0 · Negative	140 Participants	—
Number of Participants With Rotavirus Vaccine Shedding Day 0 · Positive	0 Participants	—
Number of Participants With Rotavirus Vaccine Shedding Day 0 · No stool	100 Participants	—
Number of Participants With Rotavirus Vaccine Shedding Day 4 · Negative	234 Participants	—
Number of Participants With Rotavirus Vaccine Shedding Day 4 · Positive	4 Participants	—
Number of Participants With Rotavirus Vaccine Shedding Day 4 · No stool	2 Participants	—
Number of Participants With Rotavirus Vaccine Shedding Day 7 · Negative	234 Participants	—
Number of Participants With Rotavirus Vaccine Shedding Day 7 · Positive	6 Participants	—
Number of Participants With Rotavirus Vaccine Shedding Day 7 · No stool	0 Participants	—

Adverse Events

Measles-rubella and Rotavirus Vaccines

Serious events: 10 serious events

Other events: 63 other events

Deaths: 0 deaths

Measles-rubella Vaccine

Serious events: 6 serious events

Other events: 68 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Measles-rubella and Rotavirus Vaccines n=240 participants at risk receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine and one 1.0 ml dose of oral Rotarix vaccine at 9 months of age Rotarix vaccine: one 1.0 ml dose of oral rotavirus vaccine at 9 months of age measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine	Measles-rubella Vaccine n=240 participants at risk receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine at 9 months of age measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine
Infections and infestations Urinary tract infection	0.83% 2/240 • Number of events 2 • 2 months after vaccination Local and systemic adverse events were assessed on days 4, 7, 11, 14, and 28 after vaccination through home visits by trained field workers. Solicited adverse events includes diarrhea, fever, vomiting, loss of appetite, irritability, and signs of intussusception (colicky abdominal pain or paroxysms of crying/screaming, abdominal distension or mass, intermittent irritability or lethargy with behavioral changes, stool with blood or "red currant jelly," and/or vomiting ≥2 episodes/day).	0.00% 0/240 • 2 months after vaccination Local and systemic adverse events were assessed on days 4, 7, 11, 14, and 28 after vaccination through home visits by trained field workers. Solicited adverse events includes diarrhea, fever, vomiting, loss of appetite, irritability, and signs of intussusception (colicky abdominal pain or paroxysms of crying/screaming, abdominal distension or mass, intermittent irritability or lethargy with behavioral changes, stool with blood or "red currant jelly," and/or vomiting ≥2 episodes/day).
Infections and infestations Acute bronchiolitis	0.42% 1/240 • Number of events 1 • 2 months after vaccination Local and systemic adverse events were assessed on days 4, 7, 11, 14, and 28 after vaccination through home visits by trained field workers. Solicited adverse events includes diarrhea, fever, vomiting, loss of appetite, irritability, and signs of intussusception (colicky abdominal pain or paroxysms of crying/screaming, abdominal distension or mass, intermittent irritability or lethargy with behavioral changes, stool with blood or "red currant jelly," and/or vomiting ≥2 episodes/day).	0.42% 1/240 • Number of events 1 • 2 months after vaccination Local and systemic adverse events were assessed on days 4, 7, 11, 14, and 28 after vaccination through home visits by trained field workers. Solicited adverse events includes diarrhea, fever, vomiting, loss of appetite, irritability, and signs of intussusception (colicky abdominal pain or paroxysms of crying/screaming, abdominal distension or mass, intermittent irritability or lethargy with behavioral changes, stool with blood or "red currant jelly," and/or vomiting ≥2 episodes/day).
Respiratory, thoracic and mediastinal disorders Acute nasopharyngitis	0.42% 1/240 • Number of events 1 • 2 months after vaccination Local and systemic adverse events were assessed on days 4, 7, 11, 14, and 28 after vaccination through home visits by trained field workers. Solicited adverse events includes diarrhea, fever, vomiting, loss of appetite, irritability, and signs of intussusception (colicky abdominal pain or paroxysms of crying/screaming, abdominal distension or mass, intermittent irritability or lethargy with behavioral changes, stool with blood or "red currant jelly," and/or vomiting ≥2 episodes/day).	0.00% 0/240 • 2 months after vaccination Local and systemic adverse events were assessed on days 4, 7, 11, 14, and 28 after vaccination through home visits by trained field workers. Solicited adverse events includes diarrhea, fever, vomiting, loss of appetite, irritability, and signs of intussusception (colicky abdominal pain or paroxysms of crying/screaming, abdominal distension or mass, intermittent irritability or lethargy with behavioral changes, stool with blood or "red currant jelly," and/or vomiting ≥2 episodes/day).
Gastrointestinal disorders Acute watery diarrhea	1.7% 4/240 • Number of events 4 • 2 months after vaccination Local and systemic adverse events were assessed on days 4, 7, 11, 14, and 28 after vaccination through home visits by trained field workers. Solicited adverse events includes diarrhea, fever, vomiting, loss of appetite, irritability, and signs of intussusception (colicky abdominal pain or paroxysms of crying/screaming, abdominal distension or mass, intermittent irritability or lethargy with behavioral changes, stool with blood or "red currant jelly," and/or vomiting ≥2 episodes/day).	1.2% 3/240 • Number of events 3 • 2 months after vaccination Local and systemic adverse events were assessed on days 4, 7, 11, 14, and 28 after vaccination through home visits by trained field workers. Solicited adverse events includes diarrhea, fever, vomiting, loss of appetite, irritability, and signs of intussusception (colicky abdominal pain or paroxysms of crying/screaming, abdominal distension or mass, intermittent irritability or lethargy with behavioral changes, stool with blood or "red currant jelly," and/or vomiting ≥2 episodes/day).
Nervous system disorders Febrile convulsion	0.00% 0/240 • 2 months after vaccination Local and systemic adverse events were assessed on days 4, 7, 11, 14, and 28 after vaccination through home visits by trained field workers. Solicited adverse events includes diarrhea, fever, vomiting, loss of appetite, irritability, and signs of intussusception (colicky abdominal pain or paroxysms of crying/screaming, abdominal distension or mass, intermittent irritability or lethargy with behavioral changes, stool with blood or "red currant jelly," and/or vomiting ≥2 episodes/day).	0.42% 1/240 • Number of events 1 • 2 months after vaccination Local and systemic adverse events were assessed on days 4, 7, 11, 14, and 28 after vaccination through home visits by trained field workers. Solicited adverse events includes diarrhea, fever, vomiting, loss of appetite, irritability, and signs of intussusception (colicky abdominal pain or paroxysms of crying/screaming, abdominal distension or mass, intermittent irritability or lethargy with behavioral changes, stool with blood or "red currant jelly," and/or vomiting ≥2 episodes/day).
Infections and infestations Pneumonia	0.42% 1/240 • Number of events 1 • 2 months after vaccination Local and systemic adverse events were assessed on days 4, 7, 11, 14, and 28 after vaccination through home visits by trained field workers. Solicited adverse events includes diarrhea, fever, vomiting, loss of appetite, irritability, and signs of intussusception (colicky abdominal pain or paroxysms of crying/screaming, abdominal distension or mass, intermittent irritability or lethargy with behavioral changes, stool with blood or "red currant jelly," and/or vomiting ≥2 episodes/day).	0.00% 0/240 • 2 months after vaccination Local and systemic adverse events were assessed on days 4, 7, 11, 14, and 28 after vaccination through home visits by trained field workers. Solicited adverse events includes diarrhea, fever, vomiting, loss of appetite, irritability, and signs of intussusception (colicky abdominal pain or paroxysms of crying/screaming, abdominal distension or mass, intermittent irritability or lethargy with behavioral changes, stool with blood or "red currant jelly," and/or vomiting ≥2 episodes/day).
Infections and infestations Pneumonia with UTI	0.42% 1/240 • Number of events 1 • 2 months after vaccination Local and systemic adverse events were assessed on days 4, 7, 11, 14, and 28 after vaccination through home visits by trained field workers. Solicited adverse events includes diarrhea, fever, vomiting, loss of appetite, irritability, and signs of intussusception (colicky abdominal pain or paroxysms of crying/screaming, abdominal distension or mass, intermittent irritability or lethargy with behavioral changes, stool with blood or "red currant jelly," and/or vomiting ≥2 episodes/day).	0.00% 0/240 • 2 months after vaccination Local and systemic adverse events were assessed on days 4, 7, 11, 14, and 28 after vaccination through home visits by trained field workers. Solicited adverse events includes diarrhea, fever, vomiting, loss of appetite, irritability, and signs of intussusception (colicky abdominal pain or paroxysms of crying/screaming, abdominal distension or mass, intermittent irritability or lethargy with behavioral changes, stool with blood or "red currant jelly," and/or vomiting ≥2 episodes/day).
Infections and infestations Severe pneumonia	0.00% 0/240 • 2 months after vaccination Local and systemic adverse events were assessed on days 4, 7, 11, 14, and 28 after vaccination through home visits by trained field workers. Solicited adverse events includes diarrhea, fever, vomiting, loss of appetite, irritability, and signs of intussusception (colicky abdominal pain or paroxysms of crying/screaming, abdominal distension or mass, intermittent irritability or lethargy with behavioral changes, stool with blood or "red currant jelly," and/or vomiting ≥2 episodes/day).	0.42% 1/240 • Number of events 1 • 2 months after vaccination Local and systemic adverse events were assessed on days 4, 7, 11, 14, and 28 after vaccination through home visits by trained field workers. Solicited adverse events includes diarrhea, fever, vomiting, loss of appetite, irritability, and signs of intussusception (colicky abdominal pain or paroxysms of crying/screaming, abdominal distension or mass, intermittent irritability or lethargy with behavioral changes, stool with blood or "red currant jelly," and/or vomiting ≥2 episodes/day).

Other adverse events

Additional Information

Jorge Flores

PATH

Phone: (202) 822-0033

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Measles-rubella and Rotavirus Vaccines n=240 participants at risk receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine and one 1.0 ml dose of oral Rotarix vaccine at 9 months of age Rotarix vaccine: one 1.0 ml dose of oral rotavirus vaccine at 9 months of age measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine	Measles-rubella Vaccine n=240 participants at risk receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine at 9 months of age measles-rubella vaccine: one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine
Gastrointestinal disorders Abdominal distension	0.00% 0/240 • 2 months after vaccination Local and systemic adverse events were assessed on days 4, 7, 11, 14, and 28 after vaccination through home visits by trained field workers. Solicited adverse events includes diarrhea, fever, vomiting, loss of appetite, irritability, and signs of intussusception (colicky abdominal pain or paroxysms of crying/screaming, abdominal distension or mass, intermittent irritability or lethargy with behavioral changes, stool with blood or "red currant jelly," and/or vomiting ≥2 episodes/day).	0.42% 1/240 • 2 months after vaccination Local and systemic adverse events were assessed on days 4, 7, 11, 14, and 28 after vaccination through home visits by trained field workers. Solicited adverse events includes diarrhea, fever, vomiting, loss of appetite, irritability, and signs of intussusception (colicky abdominal pain or paroxysms of crying/screaming, abdominal distension or mass, intermittent irritability or lethargy with behavioral changes, stool with blood or "red currant jelly," and/or vomiting ≥2 episodes/day).
Infections and infestations Conjunctivitis	0.00% 0/240 • 2 months after vaccination Local and systemic adverse events were assessed on days 4, 7, 11, 14, and 28 after vaccination through home visits by trained field workers. Solicited adverse events includes diarrhea, fever, vomiting, loss of appetite, irritability, and signs of intussusception (colicky abdominal pain or paroxysms of crying/screaming, abdominal distension or mass, intermittent irritability or lethargy with behavioral changes, stool with blood or "red currant jelly," and/or vomiting ≥2 episodes/day).	0.42% 1/240 • 2 months after vaccination Local and systemic adverse events were assessed on days 4, 7, 11, 14, and 28 after vaccination through home visits by trained field workers. Solicited adverse events includes diarrhea, fever, vomiting, loss of appetite, irritability, and signs of intussusception (colicky abdominal pain or paroxysms of crying/screaming, abdominal distension or mass, intermittent irritability or lethargy with behavioral changes, stool with blood or "red currant jelly," and/or vomiting ≥2 episodes/day).
Respiratory, thoracic and mediastinal disorders Cough	2.1% 5/240 • 2 months after vaccination Local and systemic adverse events were assessed on days 4, 7, 11, 14, and 28 after vaccination through home visits by trained field workers. Solicited adverse events includes diarrhea, fever, vomiting, loss of appetite, irritability, and signs of intussusception (colicky abdominal pain or paroxysms of crying/screaming, abdominal distension or mass, intermittent irritability or lethargy with behavioral changes, stool with blood or "red currant jelly," and/or vomiting ≥2 episodes/day).	1.7% 4/240 • 2 months after vaccination Local and systemic adverse events were assessed on days 4, 7, 11, 14, and 28 after vaccination through home visits by trained field workers. Solicited adverse events includes diarrhea, fever, vomiting, loss of appetite, irritability, and signs of intussusception (colicky abdominal pain or paroxysms of crying/screaming, abdominal distension or mass, intermittent irritability or lethargy with behavioral changes, stool with blood or "red currant jelly," and/or vomiting ≥2 episodes/day).
Gastrointestinal disorders Dysentery	3.8% 9/240 • 2 months after vaccination Local and systemic adverse events were assessed on days 4, 7, 11, 14, and 28 after vaccination through home visits by trained field workers. Solicited adverse events includes diarrhea, fever, vomiting, loss of appetite, irritability, and signs of intussusception (colicky abdominal pain or paroxysms of crying/screaming, abdominal distension or mass, intermittent irritability or lethargy with behavioral changes, stool with blood or "red currant jelly," and/or vomiting ≥2 episodes/day).	5.0% 12/240 • 2 months after vaccination Local and systemic adverse events were assessed on days 4, 7, 11, 14, and 28 after vaccination through home visits by trained field workers. Solicited adverse events includes diarrhea, fever, vomiting, loss of appetite, irritability, and signs of intussusception (colicky abdominal pain or paroxysms of crying/screaming, abdominal distension or mass, intermittent irritability or lethargy with behavioral changes, stool with blood or "red currant jelly," and/or vomiting ≥2 episodes/day).
Ear and labyrinth disorders Ear pain	0.42% 1/240 • 2 months after vaccination Local and systemic adverse events were assessed on days 4, 7, 11, 14, and 28 after vaccination through home visits by trained field workers. Solicited adverse events includes diarrhea, fever, vomiting, loss of appetite, irritability, and signs of intussusception (colicky abdominal pain or paroxysms of crying/screaming, abdominal distension or mass, intermittent irritability or lethargy with behavioral changes, stool with blood or "red currant jelly," and/or vomiting ≥2 episodes/day).	0.00% 0/240 • 2 months after vaccination Local and systemic adverse events were assessed on days 4, 7, 11, 14, and 28 after vaccination through home visits by trained field workers. Solicited adverse events includes diarrhea, fever, vomiting, loss of appetite, irritability, and signs of intussusception (colicky abdominal pain or paroxysms of crying/screaming, abdominal distension or mass, intermittent irritability or lethargy with behavioral changes, stool with blood or "red currant jelly," and/or vomiting ≥2 episodes/day).
Infections and infestations Fungal infection	0.83% 2/240 • 2 months after vaccination Local and systemic adverse events were assessed on days 4, 7, 11, 14, and 28 after vaccination through home visits by trained field workers. Solicited adverse events includes diarrhea, fever, vomiting, loss of appetite, irritability, and signs of intussusception (colicky abdominal pain or paroxysms of crying/screaming, abdominal distension or mass, intermittent irritability or lethargy with behavioral changes, stool with blood or "red currant jelly," and/or vomiting ≥2 episodes/day).	0.42% 1/240 • 2 months after vaccination Local and systemic adverse events were assessed on days 4, 7, 11, 14, and 28 after vaccination through home visits by trained field workers. Solicited adverse events includes diarrhea, fever, vomiting, loss of appetite, irritability, and signs of intussusception (colicky abdominal pain or paroxysms of crying/screaming, abdominal distension or mass, intermittent irritability or lethargy with behavioral changes, stool with blood or "red currant jelly," and/or vomiting ≥2 episodes/day).
Gastrointestinal disorders Mouth ulceration	0.42% 1/240 • 2 months after vaccination Local and systemic adverse events were assessed on days 4, 7, 11, 14, and 28 after vaccination through home visits by trained field workers. Solicited adverse events includes diarrhea, fever, vomiting, loss of appetite, irritability, and signs of intussusception (colicky abdominal pain or paroxysms of crying/screaming, abdominal distension or mass, intermittent irritability or lethargy with behavioral changes, stool with blood or "red currant jelly," and/or vomiting ≥2 episodes/day).	0.00% 0/240 • 2 months after vaccination Local and systemic adverse events were assessed on days 4, 7, 11, 14, and 28 after vaccination through home visits by trained field workers. Solicited adverse events includes diarrhea, fever, vomiting, loss of appetite, irritability, and signs of intussusception (colicky abdominal pain or paroxysms of crying/screaming, abdominal distension or mass, intermittent irritability or lethargy with behavioral changes, stool with blood or "red currant jelly," and/or vomiting ≥2 episodes/day).
Respiratory, thoracic and mediastinal disorders Nasopharyngitis	13.3% 32/240 • 2 months after vaccination Local and systemic adverse events were assessed on days 4, 7, 11, 14, and 28 after vaccination through home visits by trained field workers. Solicited adverse events includes diarrhea, fever, vomiting, loss of appetite, irritability, and signs of intussusception (colicky abdominal pain or paroxysms of crying/screaming, abdominal distension or mass, intermittent irritability or lethargy with behavioral changes, stool with blood or "red currant jelly," and/or vomiting ≥2 episodes/day).	15.8% 38/240 • 2 months after vaccination Local and systemic adverse events were assessed on days 4, 7, 11, 14, and 28 after vaccination through home visits by trained field workers. Solicited adverse events includes diarrhea, fever, vomiting, loss of appetite, irritability, and signs of intussusception (colicky abdominal pain or paroxysms of crying/screaming, abdominal distension or mass, intermittent irritability or lethargy with behavioral changes, stool with blood or "red currant jelly," and/or vomiting ≥2 episodes/day).
Gastrointestinal disorders Oral candidiasis	0.42% 1/240 • 2 months after vaccination Local and systemic adverse events were assessed on days 4, 7, 11, 14, and 28 after vaccination through home visits by trained field workers. Solicited adverse events includes diarrhea, fever, vomiting, loss of appetite, irritability, and signs of intussusception (colicky abdominal pain or paroxysms of crying/screaming, abdominal distension or mass, intermittent irritability or lethargy with behavioral changes, stool with blood or "red currant jelly," and/or vomiting ≥2 episodes/day).	0.00% 0/240 • 2 months after vaccination Local and systemic adverse events were assessed on days 4, 7, 11, 14, and 28 after vaccination through home visits by trained field workers. Solicited adverse events includes diarrhea, fever, vomiting, loss of appetite, irritability, and signs of intussusception (colicky abdominal pain or paroxysms of crying/screaming, abdominal distension or mass, intermittent irritability or lethargy with behavioral changes, stool with blood or "red currant jelly," and/or vomiting ≥2 episodes/day).
Infections and infestations Otitis media chronic	1.2% 3/240 • 2 months after vaccination Local and systemic adverse events were assessed on days 4, 7, 11, 14, and 28 after vaccination through home visits by trained field workers. Solicited adverse events includes diarrhea, fever, vomiting, loss of appetite, irritability, and signs of intussusception (colicky abdominal pain or paroxysms of crying/screaming, abdominal distension or mass, intermittent irritability or lethargy with behavioral changes, stool with blood or "red currant jelly," and/or vomiting ≥2 episodes/day).	0.00% 0/240 • 2 months after vaccination Local and systemic adverse events were assessed on days 4, 7, 11, 14, and 28 after vaccination through home visits by trained field workers. Solicited adverse events includes diarrhea, fever, vomiting, loss of appetite, irritability, and signs of intussusception (colicky abdominal pain or paroxysms of crying/screaming, abdominal distension or mass, intermittent irritability or lethargy with behavioral changes, stool with blood or "red currant jelly," and/or vomiting ≥2 episodes/day).
Infections and infestations Pneumonia	0.42% 1/240 • 2 months after vaccination Local and systemic adverse events were assessed on days 4, 7, 11, 14, and 28 after vaccination through home visits by trained field workers. Solicited adverse events includes diarrhea, fever, vomiting, loss of appetite, irritability, and signs of intussusception (colicky abdominal pain or paroxysms of crying/screaming, abdominal distension or mass, intermittent irritability or lethargy with behavioral changes, stool with blood or "red currant jelly," and/or vomiting ≥2 episodes/day).	0.42% 1/240 • 2 months after vaccination Local and systemic adverse events were assessed on days 4, 7, 11, 14, and 28 after vaccination through home visits by trained field workers. Solicited adverse events includes diarrhea, fever, vomiting, loss of appetite, irritability, and signs of intussusception (colicky abdominal pain or paroxysms of crying/screaming, abdominal distension or mass, intermittent irritability or lethargy with behavioral changes, stool with blood or "red currant jelly," and/or vomiting ≥2 episodes/day).
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.42% 1/240 • 2 months after vaccination Local and systemic adverse events were assessed on days 4, 7, 11, 14, and 28 after vaccination through home visits by trained field workers. Solicited adverse events includes diarrhea, fever, vomiting, loss of appetite, irritability, and signs of intussusception (colicky abdominal pain or paroxysms of crying/screaming, abdominal distension or mass, intermittent irritability or lethargy with behavioral changes, stool with blood or "red currant jelly," and/or vomiting ≥2 episodes/day).	0.00% 0/240 • 2 months after vaccination Local and systemic adverse events were assessed on days 4, 7, 11, 14, and 28 after vaccination through home visits by trained field workers. Solicited adverse events includes diarrhea, fever, vomiting, loss of appetite, irritability, and signs of intussusception (colicky abdominal pain or paroxysms of crying/screaming, abdominal distension or mass, intermittent irritability or lethargy with behavioral changes, stool with blood or "red currant jelly," and/or vomiting ≥2 episodes/day).
Infections and infestations Respiratory tract infection	6.7% 16/240 • 2 months after vaccination Local and systemic adverse events were assessed on days 4, 7, 11, 14, and 28 after vaccination through home visits by trained field workers. Solicited adverse events includes diarrhea, fever, vomiting, loss of appetite, irritability, and signs of intussusception (colicky abdominal pain or paroxysms of crying/screaming, abdominal distension or mass, intermittent irritability or lethargy with behavioral changes, stool with blood or "red currant jelly," and/or vomiting ≥2 episodes/day).	5.4% 13/240 • 2 months after vaccination Local and systemic adverse events were assessed on days 4, 7, 11, 14, and 28 after vaccination through home visits by trained field workers. Solicited adverse events includes diarrhea, fever, vomiting, loss of appetite, irritability, and signs of intussusception (colicky abdominal pain or paroxysms of crying/screaming, abdominal distension or mass, intermittent irritability or lethargy with behavioral changes, stool with blood or "red currant jelly," and/or vomiting ≥2 episodes/day).
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.42% 1/240 • 2 months after vaccination Local and systemic adverse events were assessed on days 4, 7, 11, 14, and 28 after vaccination through home visits by trained field workers. Solicited adverse events includes diarrhea, fever, vomiting, loss of appetite, irritability, and signs of intussusception (colicky abdominal pain or paroxysms of crying/screaming, abdominal distension or mass, intermittent irritability or lethargy with behavioral changes, stool with blood or "red currant jelly," and/or vomiting ≥2 episodes/day).	0.00% 0/240 • 2 months after vaccination Local and systemic adverse events were assessed on days 4, 7, 11, 14, and 28 after vaccination through home visits by trained field workers. Solicited adverse events includes diarrhea, fever, vomiting, loss of appetite, irritability, and signs of intussusception (colicky abdominal pain or paroxysms of crying/screaming, abdominal distension or mass, intermittent irritability or lethargy with behavioral changes, stool with blood or "red currant jelly," and/or vomiting ≥2 episodes/day).
Infections and infestations Urinary tract infection	0.42% 1/240 • 2 months after vaccination Local and systemic adverse events were assessed on days 4, 7, 11, 14, and 28 after vaccination through home visits by trained field workers. Solicited adverse events includes diarrhea, fever, vomiting, loss of appetite, irritability, and signs of intussusception (colicky abdominal pain or paroxysms of crying/screaming, abdominal distension or mass, intermittent irritability or lethargy with behavioral changes, stool with blood or "red currant jelly," and/or vomiting ≥2 episodes/day).	0.00% 0/240 • 2 months after vaccination Local and systemic adverse events were assessed on days 4, 7, 11, 14, and 28 after vaccination through home visits by trained field workers. Solicited adverse events includes diarrhea, fever, vomiting, loss of appetite, irritability, and signs of intussusception (colicky abdominal pain or paroxysms of crying/screaming, abdominal distension or mass, intermittent irritability or lethargy with behavioral changes, stool with blood or "red currant jelly," and/or vomiting ≥2 episodes/day).
Infections and infestations Varicella	0.00% 0/240 • 2 months after vaccination Local and systemic adverse events were assessed on days 4, 7, 11, 14, and 28 after vaccination through home visits by trained field workers. Solicited adverse events includes diarrhea, fever, vomiting, loss of appetite, irritability, and signs of intussusception (colicky abdominal pain or paroxysms of crying/screaming, abdominal distension or mass, intermittent irritability or lethargy with behavioral changes, stool with blood or "red currant jelly," and/or vomiting ≥2 episodes/day).	0.42% 1/240 • 2 months after vaccination Local and systemic adverse events were assessed on days 4, 7, 11, 14, and 28 after vaccination through home visits by trained field workers. Solicited adverse events includes diarrhea, fever, vomiting, loss of appetite, irritability, and signs of intussusception (colicky abdominal pain or paroxysms of crying/screaming, abdominal distension or mass, intermittent irritability or lethargy with behavioral changes, stool with blood or "red currant jelly," and/or vomiting ≥2 episodes/day).