Age: 0.33
Sex: M
Vaccine: 6VAX-F, PNC13, RV1
Symptoms: Seizure
Clinical narrative: This case was reported in a literature article and described the occurrence of convulsion in a infant male subject who received DTPa-HBV-IPV+Hib vaccine for prophylaxis. Co-suspect products included PREVNAR 13 for prophylaxis. Concomitant products included INFANRIX HEXA, ROTARIX and PREVNAR 13. On an unknown date, 3 days after receiving DTPa-HBV-IPV+Hib vaccine and Rotavirus vaccine, the subject developed mild - grade 1 convulsion. Serious criteria included GSK medically significant and other: serious per reporter. The outcome of convulsion was recovered/resolved. The investigator considered that there was a reasonable possibility that the convulsion may have been caused by DTPa-HBV-IPV+Hib vaccine and Rotavirus vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of mild convulsion in a male infant who was vaccinated with INFANRIX-HEXA, ROTARIX (GlaxoSmithKline) and PREVNAR 13 (Pfizer) for prophylaxis. This case corresponds to Supplemental Digital Content 4 in this literature article. The patient was a part of a comprehensive summary and analysis of integrated safety data from 6 Phase IIb/III clinical studies (Protocols 004, 005, 006, 007, 008, and PRI01C) conducted in the 3 different places, with the final formulation of DTaP5-HB-IPV-Hib (Vaxelis) vaccine. The studies provided a rigorous assessment of the overall safety profile of DTaP5-HB-IPV-Hib vaccine across a broad range of geographies, populations, and vaccination schedules. The patient's age at the time of enrollment was 69 days. The patient was from 008 group (NCT01480258), conducted in 3 different countries. The patient was from control group. No information on patient's medical or family history or concurrent condition or concomitant medication was provided. On unspecified dates, at the age of 2 and 4 months, the patient received 2 doses of INFANRIX HEXA, ROTARIX and PREVNAR 13 (administration route and site unspecified; batch number not provided). On an unspecified date, 3 days after vaccinations, the patient developed mild convulsion. The duration of illness was 47 days. This case has been considered serious per reporter. Treatment was unknown. The author considered the event of mild convulsion related to INFANRIX-HEXA and ROTARIX. The author concluded, "DTaP5-HB-IPV-Hib vaccine administered as a 2- or 3-dose infant series plus Toddler Dose or as 3-dose infant series to over 6,800 children, has an acceptable safety. profile generally similar to that of control vaccines, based on a low incidence of severe AEs, vaccine-related SAEs, and AEs leading to discontinuation. Clinically relevant interference has not been seen with concomitant administration of pneumococcal conjugate, rotavirus, meningococcal group C conjugate, and measles-mumps-rubella-varicella vaccines.3,8-10 DTaP5- HB-IPV-Hib vaccine provides a new, fully-liquid, and convenient hexavalent vaccination option for use with various vaccination schedules." This is 1 of 5 valid cases reported in the same literature article. The article corresponding to this case is not available for regulatory submission due to copyright restriction. Follow-up information received on 09-Jan-2019 from author: Country of occurrence changed. Due to change in the country of occurrence, negative acknowledgement was received for VAERS report ; the information submitted previously under the ID US2018GSK228126 was duplicate in this case in order to allow VAERS report to be submitted.; Sender's Comments: An infant male patient experienced convulsions 3 days after receiving INFANRIX HEXA, PREVNAR 13 and ROTARIX vaccines. Despite of temporal association,causal association with INFANRIX HEXA is indterminate considering 3 vaccines adminstred concomitantly.