Trial Outcomes & Findings for Study of the Safety of Menactra® Vaccine When Administered With Other Pediatric Vaccines to Healthy Toddlers (NCT NCT00483574)

Last Updated: 2016-05-16

Results Overview

Solicited injection site reactions: tenderness, Erythema (Redness), and Swelling. Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, and Irritability

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1378 participants

Primary outcome timeframe

Day 0 to 7 Post-vaccination

Results posted on

2016-05-16

Participant Flow

Participants were enrolled from 30 May 2007 to 28 March 2008 at 82 US clinical centers.

A total of 1378 participants met inclusion and exclusion criteria, of which 1374 were vaccinated and included in this analysis.

Participant milestones

Participant milestones
Measure	Group 1: Menactra and Routine Pediatric Vaccines Participants received Menactra alone at age 9 months and Menactra concomitantly with routine pediatric vaccines Measles, mumps and rubella (MMR: M-M-R®II) and varicella (V: Varivax), (0.5 mL Subcutaneous, respectively); pneumococcal conjugate (PCV), and hepatitis A (HepA) at age 12 months. (0.5 mL, intramuscular, respectively)	Group 2: Routine Pediatric Vaccines Participants received routine pediatric vaccines, Measles, mumps and rubella (MMR: M-M-R®II) and varicella (V: Varivax), (0.5 mL Subcutaneous, respectively); pneumococcal conjugate (PCV), and hepatitis A (HepA) at age 12 months. (0.5 mL, intramuscular, respectively)
Overall Study STARTED	1053	321
Overall Study COMPLETED	951	308
Overall Study NOT COMPLETED	102	13

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1: Menactra and Routine Pediatric Vaccines Participants received Menactra alone at age 9 months and Menactra concomitantly with routine pediatric vaccines Measles, mumps and rubella (MMR: M-M-R®II) and varicella (V: Varivax), (0.5 mL Subcutaneous, respectively); pneumococcal conjugate (PCV), and hepatitis A (HepA) at age 12 months. (0.5 mL, intramuscular, respectively)	Group 2: Routine Pediatric Vaccines Participants received routine pediatric vaccines, Measles, mumps and rubella (MMR: M-M-R®II) and varicella (V: Varivax), (0.5 mL Subcutaneous, respectively); pneumococcal conjugate (PCV), and hepatitis A (HepA) at age 12 months. (0.5 mL, intramuscular, respectively)
Overall Study Adverse Event	6	0
Overall Study Protocol Violation	28	9
Overall Study Lost to Follow-up	16	4
Overall Study Withdrawal by Subject	52	0

Baseline Characteristics

Study of the Safety of Menactra® Vaccine When Administered With Other Pediatric Vaccines to Healthy Toddlers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1: Menactra and Routine Pediatric Vaccines n=1053 Participants Participants received Menactra alone at age 9 months and Menactra concomitantly with routine pediatric vaccines Measles, mumps and rubella (MMR: M-M-R®II) and varicella (V: Varivax), (0.5 mL Subcutaneous, respectively); pneumococcal conjugate (PCV), and hepatitis A (HepA) at age 12 months. (0.5 mL, intramuscular, respectively)	Group 2: Routine Pediatric Vaccines n=321 Participants Participants received routine pediatric vaccines, Measles, mumps and rubella (MMR: M-M-R®II) and varicella (V: Varivax), (0.5 mL Subcutaneous, respectively); pneumococcal conjugate (PCV), and hepatitis A (HepA) at age 12 months. (0.5 mL, intramuscular, respectively)	Total n=1374 Participants Total of all reporting groups
Age, Categorical <=18 years	1053 Participants n=5 Participants	321 Participants n=7 Participants	1374 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	282.8 Days STANDARD_DEVIATION 10.79 • n=5 Participants	374.6 Days STANDARD_DEVIATION 8.93 • n=7 Participants	304.3 Days STANDARD_DEVIATION 40.22 • n=5 Participants
Sex: Female, Male Female	511 Participants n=5 Participants	158 Participants n=7 Participants	669 Participants n=5 Participants
Sex: Female, Male Male	542 Participants n=5 Participants	163 Participants n=7 Participants	705 Participants n=5 Participants
Region of Enrollment United States	1053 participants n=5 Participants	321 participants n=7 Participants	1374 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 0 to 7 Post-vaccination

Population: Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population. Data on 23 participants in Group 1 that received MMR+V vaccines instead of a MMRV single vaccine in addition to the PCV and HepA vaccines were analyzed separately.

Outcome measures

Outcome measures
Measure	Group 1: Menactra and Routine Pediatric Vaccines n=1030 Participants Participants received Menactra alone at age 9 months and Menactra concomitantly with routine pediatric vaccines Measles, mumps and rubella (MMR: M-M-R®II) and varicella (V: Varivax), (0.5 mL Subcutaneous, respectively); pneumococcal conjugate (PCV), and hepatitis A (HepA) at age 12 months. (0.5 mL, intramuscular, respectively)	Group 2: Routine Pediatric Vaccines n=321 Participants Participants received routine pediatric vaccines, Measles, mumps and rubella (MMR: M-M-R®II) and varicella (V: Varivax), (0.5 mL Subcutaneous, respectively); pneumococcal conjugate (PCV), and hepatitis A (HepA) at age 12 months. (0.5 mL, intramuscular, respectively)
Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. Any Erythema at 12 Months - Menactra	30 Percentage of participants	NA Percentage of participants Participants did not receive Menactra vaccine
Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. Grade 3 Erythema (≥ 2.0 in [≥ 5.0 cm])	0 Percentage of participants	1 Percentage of participants
Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. Any Tenderness at 12 Months - MMRV	39 Percentage of participants	43 Percentage of participants
Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. Grade 3 Tenderness (Cries when limb is moved)	1 Percentage of participants	0 Percentage of participants
Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. Grade 3 Vomiting (≥ 6 episodes per 24 hours)	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. Any Crying Abnormal at 9 Months	33 Percentage of participants	0 Percentage of participants
Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. Grade 3 Crying Abnormal (> 3 hours)	2 Percentage of participants	1 Percentage of participants
Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. Any Drowsiness at 9 Months	30 Percentage of participants	0 Percentage of participants
Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. Any Swelling at 12 Months - Menactra	16 Percentage of participants	NA Percentage of participants Participants did not receive Menactra vaccine
Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. Any Erythema at 12 Months - MMRV	23 Percentage of participants	33 Percentage of participants
Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. Any Swelling at 12 Months - MMRV	12 Percentage of participants	14 Percentage of participants
Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. Grade 3 Swelling (≥ 2.0 in [≥ 5.0 cm])	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. Any Injection Site Reaction at 12 Months, PCV	53 Percentage of participants	56 Percentage of participants
Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. Any Injection Site Reaction at 12 Months, MMRV	44 Percentage of participants	59 Percentage of participants
Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. Any Injection Site Reaction at 9 Months - Menactra	52 Percentage of participants	NA Percentage of participants Participants did not receive Menactra vaccine
Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. Any Tenderness at 9 Months - Menactra	37 Percentage of participants	NA Percentage of participants Participants did not receive Menactra vaccine
Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. Any Erythema at 9 Months - Menactra	30 Percentage of participants	NA Percentage of participants Participants did not receive Menactra vaccine
Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. Any Swelling at 9 Months - Menactra	17 Percentage of participants	NA Percentage of participants Participants did not receive Menactra vaccine
Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. Any Injection Site Reaction at 12 Months -Menactra	58 Percentage of participants	NA Percentage of participants Participants did not receive Menactra vaccine
Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. Any Tenderness at 12 Months - Menactra	49 Percentage of participants	NA Percentage of participants Participants did not receive Menactra vaccine
Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. Any Tenderness at 12 Months - PCV	46 Percentage of participants	46 Percentage of participants
Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. Any Erythema at 12 Months - PCV	29 Percentage of participants	33 Percentage of participants
Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. Any Swelling at 12 Months - PCV	20 Percentage of participants	17 Percentage of participants
Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. Any Injection Site Reaction at 12 Months, HepA	50 Percentage of participants	52 Percentage of participants
Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. Any Tenderness at 12 Months - HepA	43 Percentage of participants	41 Percentage of participants
Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. Any Erythema at 12 Months - HepA	25 Percentage of participants	27 Percentage of participants
Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. Any Swelling at 12 Months - HepA	16 Percentage of participants	14 Percentage of participants
Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. Any Systemic Reaction at 9 Months	69 Percentage of participants	0 Percentage of participants
Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. Any Fever, (rectal or oral temperature route)	25 Percentage of participants	22 Percentage of participants
Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. Grade 3 Fever (>103.1 ºF [>39.5 ºC]), Any Route	2 Percentage of participants	3 Percentage of participants
Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. Any Vomiting at 9 Months	14 Percentage of participants	0 Percentage of participants
Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. Grade 3 Drowsiness (Sleeps most of time)	1 Percentage of participants	1 Percentage of participants
Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. Any Appetite Lost at 9 Months	30 Percentage of participants	0 Percentage of participants
Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. Grade 3 Appetite Lost (Refuses ≥ 3 feeds/meals)	3 Percentage of participants	1 Percentage of participants
Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. Any Irritability at 9 Months	57 Percentage of participants	0 Percentage of participants
Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. Grade 3 Irritability (Inconsolable)	4 Percentage of participants	4 Percentage of participants
Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. Any Solicited Systemic Reaction at 12 Months	73 Percentage of participants	75 Percentage of participants
Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. Any Vomiting at 12 Months	11 Percentage of participants	10 Percentage of participants
Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. Any Crying Abnormal at 12 Months	40 Percentage of participants	39 Percentage of participants
Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. Any Drowsiness at 12 Months	40 Percentage of participants	39 Percentage of participants
Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. Any Appetite Lost at 12 Months	36 Percentage of participants	32 Percentage of participants
Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. Any Irritability at 12 Months	62 Percentage of participants	65 Percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0 to 7 Post-vaccination

Population: Summary of the safety analysis of the 23 participants in Group 1 that received MMR+V vaccines instead of a MMRV single vaccine in addition to the PCV and HepA vaccines.

Outcome measures

Outcome measures
Measure	Group 1: Menactra and Routine Pediatric Vaccines n=23 Participants Participants received Menactra alone at age 9 months and Menactra concomitantly with routine pediatric vaccines Measles, mumps and rubella (MMR: M-M-R®II) and varicella (V: Varivax), (0.5 mL Subcutaneous, respectively); pneumococcal conjugate (PCV), and hepatitis A (HepA) at age 12 months. (0.5 mL, intramuscular, respectively)	Group 2: Routine Pediatric Vaccines Participants received routine pediatric vaccines, Measles, mumps and rubella (MMR: M-M-R®II) and varicella (V: Varivax), (0.5 mL Subcutaneous, respectively); pneumococcal conjugate (PCV), and hepatitis A (HepA) at age 12 months. (0.5 mL, intramuscular, respectively)
Safety Overview After Any Vaccination in Participants Who Received MMR+V Injection Site Reaction at 12-Month, HepA	65 Percentage of participants	—
Safety Overview After Any Vaccination in Participants Who Received MMR+V Injection Site Reaction at 9-Month, Menactra	44 Percentage of participants	—
Safety Overview After Any Vaccination in Participants Who Received MMR+V Injection Site Reaction at 12-Month, Menactra	57 Percentage of participants	—
Safety Overview After Any Vaccination in Participants Who Received MMR+V Injection Site Reaction at 12-Month, MMR	52 Percentage of participants	—
Safety Overview After Any Vaccination in Participants Who Received MMR+V Injection Site Reaction at 12-Month, Varivax	41 Percentage of participants	—
Safety Overview After Any Vaccination in Participants Who Received MMR+V Injection Site Reaction at 12-Month, PCV	68 Percentage of participants	—
Safety Overview After Any Vaccination in Participants Who Received MMR+V Any Solicited Systemic Reaction at 9-Month vac	52 Percentage of participants	—
Safety Overview After Any Vaccination in Participants Who Received MMR+V Any Solicited Systemic Reaction at 12-Month vac	70 Percentage of participants	—
Safety Overview After Any Vaccination in Participants Who Received MMR+V Unsolicited Adverse Event at 9-Month	52 Percentage of participants	—
Safety Overview After Any Vaccination in Participants Who Received MMR+V Unsolicited Adverse Event at 12-Month	36 Percentage of participants	—
Safety Overview After Any Vaccination in Participants Who Received MMR+V Serious Adverse Events	0 Percentage of participants	—

Adverse Events

Group 1: Menactra and Routine Pediatric Vaccines

Serious events: 42 serious events

Other events: 530 other events

Deaths: 0 deaths

Group 2: Routine Pediatric Vaccines

Serious events: 5 serious events

Other events: 95 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Group 1: Menactra and Routine Pediatric Vaccines n=1053 participants at risk Participants received Menactra alone at age 9 months and Menactra concomitantly with routine pediatric vaccines Measles, mumps and rubella (MMR: M-M-R®II) and varicella (V: Varivax), (0.5 mL Subcutaneous, respectively); pneumococcal conjugate (PCV), and hepatitis A (HepA) at age 12 months. (0.5 mL, intramuscular, respectively)	Group 2: Routine Pediatric Vaccines n=321 participants at risk Participants received routine pediatric vaccines, Measles, mumps and rubella (MMR: M-M-R®II) and varicella (V: Varivax), (0.5 mL Subcutaneous, respectively); pneumococcal conjugate (PCV), and hepatitis A (HepA) at age 12 months. (0.5 mL, intramuscular, respectively)
Gastrointestinal disorders Diarrhoea	10.4% 109/1053 • Number of events 126 • Adverse events data were collected from the day of vaccination for up to 6 months after the last vaccination.	5.6% 18/321 • Number of events 20 • Adverse events data were collected from the day of vaccination for up to 6 months after the last vaccination.
General disorders Injection site bruising	8.1% 85/1053 • Number of events 102 • Adverse events data were collected from the day of vaccination for up to 6 months after the last vaccination.	5.6% 18/321 • Number of events 20 • Adverse events data were collected from the day of vaccination for up to 6 months after the last vaccination.
General disorders Pyrexia	6.2% 65/1053 • Number of events 76 • Adverse events data were collected from the day of vaccination for up to 6 months after the last vaccination.	5.3% 17/321 • Number of events 18 • Adverse events data were collected from the day of vaccination for up to 6 months after the last vaccination.
Infections and infestations Otitis media	17.4% 183/1053 • Number of events 210 • Adverse events data were collected from the day of vaccination for up to 6 months after the last vaccination.	8.1% 26/321 • Number of events 27 • Adverse events data were collected from the day of vaccination for up to 6 months after the last vaccination.
Infections and infestations Upper respiratory tract infection	14.2% 150/1053 • Number of events 165 • Adverse events data were collected from the day of vaccination for up to 6 months after the last vaccination.	5.0% 16/321 • Number of events 17 • Adverse events data were collected from the day of vaccination for up to 6 months after the last vaccination.
Respiratory, thoracic and mediastinal disorders Cough	12.6% 133/1053 • Number of events 146 • Adverse events data were collected from the day of vaccination for up to 6 months after the last vaccination.	4.0% 13/321 • Number of events 13 • Adverse events data were collected from the day of vaccination for up to 6 months after the last vaccination.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	7.8% 82/1053 • Number of events 90 • Adverse events data were collected from the day of vaccination for up to 6 months after the last vaccination.	2.2% 7/321 • Number of events 7 • Adverse events data were collected from the day of vaccination for up to 6 months after the last vaccination.
Skin and subcutaneous tissue disorders Rash	5.0% 53/1053 • Number of events 55 • Adverse events data were collected from the day of vaccination for up to 6 months after the last vaccination.	3.4% 11/321 • Number of events 11 • Adverse events data were collected from the day of vaccination for up to 6 months after the last vaccination.

Additional Information

Medical Director

Sanofi Pasteur Inc.

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
Publication restrictions are in place

Restriction type: OTHER

Measure	Group 1: Menactra and Routine Pediatric Vaccines n=1053 participants at risk Participants received Menactra alone at age 9 months and Menactra concomitantly with routine pediatric vaccines Measles, mumps and rubella (MMR: M-M-R®II) and varicella (V: Varivax), (0.5 mL Subcutaneous, respectively); pneumococcal conjugate (PCV), and hepatitis A (HepA) at age 12 months. (0.5 mL, intramuscular, respectively)	Group 2: Routine Pediatric Vaccines n=321 participants at risk Participants received routine pediatric vaccines, Measles, mumps and rubella (MMR: M-M-R®II) and varicella (V: Varivax), (0.5 mL Subcutaneous, respectively); pneumococcal conjugate (PCV), and hepatitis A (HepA) at age 12 months. (0.5 mL, intramuscular, respectively)
Congenital, familial and genetic disorders Inborn error of metabolism	0.09% 1/1053 • Number of events 1 • Adverse events data were collected from the day of vaccination for up to 6 months after the last vaccination.	0.00% 0/321 • Adverse events data were collected from the day of vaccination for up to 6 months after the last vaccination.
Gastrointestinal disorders Vomiting	0.09% 1/1053 • Number of events 1 • Adverse events data were collected from the day of vaccination for up to 6 months after the last vaccination.	0.00% 0/321 • Adverse events data were collected from the day of vaccination for up to 6 months after the last vaccination.
Immune system disorders Drug Hypersensitivity	0.00% 0/1053 • Adverse events data were collected from the day of vaccination for up to 6 months after the last vaccination.	0.31% 1/321 • Number of events 1 • Adverse events data were collected from the day of vaccination for up to 6 months after the last vaccination.
Infections and infestations Bronchiolitis	0.47% 5/1053 • Number of events 6 • Adverse events data were collected from the day of vaccination for up to 6 months after the last vaccination.	0.00% 0/321 • Adverse events data were collected from the day of vaccination for up to 6 months after the last vaccination.
Infections and infestations Campylobacter intestinal infection	0.09% 1/1053 • Number of events 1 • Adverse events data were collected from the day of vaccination for up to 6 months after the last vaccination.	0.00% 0/321 • Adverse events data were collected from the day of vaccination for up to 6 months after the last vaccination.
Infections and infestations Cellulitis	0.00% 0/1053 • Adverse events data were collected from the day of vaccination for up to 6 months after the last vaccination.	0.31% 1/321 • Number of events 1 • Adverse events data were collected from the day of vaccination for up to 6 months after the last vaccination.
Infections and infestations Croup Infections	0.19% 2/1053 • Number of events 2 • Adverse events data were collected from the day of vaccination for up to 6 months after the last vaccination.	0.62% 2/321 • Number of events 2 • Adverse events data were collected from the day of vaccination for up to 6 months after the last vaccination.
Infections and infestations Gastroenteritis	0.09% 1/1053 • Number of events 1 • Adverse events data were collected from the day of vaccination for up to 6 months after the last vaccination.	0.00% 0/321 • Adverse events data were collected from the day of vaccination for up to 6 months after the last vaccination.
Infections and infestations Mastoiditis	0.19% 2/1053 • Number of events 2 • Adverse events data were collected from the day of vaccination for up to 6 months after the last vaccination.	0.00% 0/321 • Adverse events data were collected from the day of vaccination for up to 6 months after the last vaccination.
Infections and infestations Pneumonia	0.19% 2/1053 • Number of events 2 • Adverse events data were collected from the day of vaccination for up to 6 months after the last vaccination.	0.00% 0/321 • Adverse events data were collected from the day of vaccination for up to 6 months after the last vaccination.
Infections and infestations Pneumonia respiratory syncytial viral	0.19% 2/1053 • Number of events 2 • Adverse events data were collected from the day of vaccination for up to 6 months after the last vaccination.	0.00% 0/321 • Adverse events data were collected from the day of vaccination for up to 6 months after the last vaccination.
Infections and infestations Respiratory syncytial virus infection	0.09% 1/1053 • Number of events 1 • Adverse events data were collected from the day of vaccination for up to 6 months after the last vaccination.	0.00% 0/321 • Adverse events data were collected from the day of vaccination for up to 6 months after the last vaccination.
Infections and infestations Staphylococcal abscess	0.19% 2/1053 • Number of events 2 • Adverse events data were collected from the day of vaccination for up to 6 months after the last vaccination.	0.00% 0/321 • Adverse events data were collected from the day of vaccination for up to 6 months after the last vaccination.
Infections and infestations Upper respiratory tract infection	0.09% 1/1053 • Number of events 1 • Adverse events data were collected from the day of vaccination for up to 6 months after the last vaccination.	0.00% 0/321 • Adverse events data were collected from the day of vaccination for up to 6 months after the last vaccination.
Infections and infestations Viral rash	0.09% 1/1053 • Number of events 1 • Adverse events data were collected from the day of vaccination for up to 6 months after the last vaccination.	0.00% 0/321 • Adverse events data were collected from the day of vaccination for up to 6 months after the last vaccination.
Injury, poisoning and procedural complications Burns third degree	0.09% 1/1053 • Number of events 1 • Adverse events data were collected from the day of vaccination for up to 6 months after the last vaccination.	0.00% 0/321 • Adverse events data were collected from the day of vaccination for up to 6 months after the last vaccination.
Injury, poisoning and procedural complications Respiratory fume inhalation disorder	0.09% 1/1053 • Number of events 1 • Adverse events data were collected from the day of vaccination for up to 6 months after the last vaccination.	0.00% 0/321 • Adverse events data were collected from the day of vaccination for up to 6 months after the last vaccination.
Injury, poisoning and procedural complications Thermal burn	0.09% 1/1053 • Number of events 1 • Adverse events data were collected from the day of vaccination for up to 6 months after the last vaccination.	0.00% 0/321 • Adverse events data were collected from the day of vaccination for up to 6 months after the last vaccination.
Metabolism and nutrition disorders Dehydration	0.28% 3/1053 • Number of events 3 • Adverse events data were collected from the day of vaccination for up to 6 months after the last vaccination.	0.00% 0/321 • Adverse events data were collected from the day of vaccination for up to 6 months after the last vaccination.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/1053 • Adverse events data were collected from the day of vaccination for up to 6 months after the last vaccination.	0.31% 1/321 • Number of events 1 • Adverse events data were collected from the day of vaccination for up to 6 months after the last vaccination.
Nervous system disorders Convulsion	0.19% 2/1053 • Number of events 2 • Adverse events data were collected from the day of vaccination for up to 6 months after the last vaccination.	0.00% 0/321 • Adverse events data were collected from the day of vaccination for up to 6 months after the last vaccination.
Nervous system disorders Febrile convulsion	0.66% 7/1053 • Number of events 8 • Adverse events data were collected from the day of vaccination for up to 6 months after the last vaccination.	0.00% 0/321 • Adverse events data were collected from the day of vaccination for up to 6 months after the last vaccination.
Psychiatric disorders Breath holding	0.09% 1/1053 • Number of events 1 • Adverse events data were collected from the day of vaccination for up to 6 months after the last vaccination.	0.00% 0/321 • Adverse events data were collected from the day of vaccination for up to 6 months after the last vaccination.
Respiratory, thoracic and mediastinal disorders Asphyxia	0.09% 1/1053 • Number of events 1 • Adverse events data were collected from the day of vaccination for up to 6 months after the last vaccination.	0.00% 0/321 • Adverse events data were collected from the day of vaccination for up to 6 months after the last vaccination.
Respiratory, thoracic and mediastinal disorders Asthma	0.38% 4/1053 • Number of events 4 • Adverse events data were collected from the day of vaccination for up to 6 months after the last vaccination.	0.00% 0/321 • Adverse events data were collected from the day of vaccination for up to 6 months after the last vaccination.
Respiratory, thoracic and mediastinal disorders Bronchial hyperactivity	0.09% 1/1053 • Number of events 1 • Adverse events data were collected from the day of vaccination for up to 6 months after the last vaccination.	0.00% 0/321 • Adverse events data were collected from the day of vaccination for up to 6 months after the last vaccination.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.09% 1/1053 • Number of events 1 • Adverse events data were collected from the day of vaccination for up to 6 months after the last vaccination.	0.00% 0/321 • Adverse events data were collected from the day of vaccination for up to 6 months after the last vaccination.