Post-marketing safety surveillance study of a 9-valent human papillomavirus vaccine in individuals aged 16–26 years in Chongqing, China

Figures & data

Table 1. Subject disposition.

	Enrolled Population (N = 1000)
Subjects signed ICF (enrolled)	1000
Subjects who completed the study (n, %)	982
Subjects who discontinued from the study (n, %)	18
Reasons for discontinuation
Pregnancy/Planned pregnancy	9
Adverse event	3
Investigator’s decision	3
Subject withdraw the informed consent	2
Lost follow-up	1
Safety set (SS) (n, %)	1000
Subjects excluded from SS (n, %)	0

Table 2. Baseline characteristics of study participants.

	N = 1000
Age (years)
n(nmiss)	1000
Mean(SD)	23.32 (1.82)
Median	24
Age group (n, %)
16–20 years	43 (4.30%)
20–26 years	957 (95.70%)
Income level(RMB/month, n, %)
1–5000	372 (37.20%)
5001–8000	288 (28.8%)
8001–17000	59 (5.9%)
>17000	5 (0.50%)
No income	276 (27.6%)
Education
Junior secondary education	11 (1.1%)
Senior secondary education	386 (38.6%)
Bachelor’s or equivalent level	546 (54.6%)
Master’s level and above	57 (5.7%)
Marriage status (n, %)
Married/cohabiting	176 (17.6%)
Single	824 (82.4%)
Occupations (n, %)
Student	227 (22.7%)
Healthcare practitioners	165 (16.5%)
Office and administrative support	115 (11.5%)
Sales workers	46 (4.6%)
Manager	12 (1.2%)
Production workers	2 (0.2%)
Other occupation	433 (43.3%)

Table 3. HPV 9 Administration information.

		N = 1000
HPV 9 doses received (n, %)	At least one dose	1000 (100%)
	Two doses	992 (99.2%)
	Three doses	982 (98.2%)
Time from second dose to first dose (days)	n(nmiss)	992 (8)
	Mean(SD)	48.73 (8.28)
	Median	46
	Q1, Q3	46, 49
	Min, Max	43, 135
Time from third dose to second dose(days)	n(nmiss)	982 (18)
	Mean(SD)	98.1 (13.17)
	Median	91
	Q1, Q3	91, 97
	Min, Max	86, 181
Received all three doses within one year	No	0
	Yes	982
	Total	982

Table 4. The summary of AE.

	SS(N = 1000)
	Number of AE	Number of Subject with one or more AEs	Percentage of Subject with one or more AEs
AEs within 30 days after any dose	2107	685	68.5%
SAEs	8	4	0.4%
HPV9-related AEs	1741	625	62.5%
HPV9-related SAEs	0	0	0.0%
Death	0	0	0.0%
Reasons for discontinuation of HPV9 Vaccination	9	3	0.3%
AEs	9	3	0.3%
HPV9-related AEs	7	2	0.2%
SAEs	1	1	0.1%
HPV9-related SAEs	0	0	0.0%
AEs of special interest	4	4	0.4%

Table 5. AEs occurred within 30 days following any HPV9 vaccination.

	Number of AE	Number of Subject with one or more AEs	Percentage of Subject with one or more AEs (N = 1000)
Vaccination-site	1479	601	60.1%
Pain	960	547	54.7%
Swelling	248	193	19.3%
Induration	104	90	9.0%
Discomfort	52	46	4.6%
Erythema	33	31	3.1%
Pruritus	13	12	1.2%
Hypoaesthesia	10	9	0.9%
Other	59	47	4.7%
Non-vaccination-site	628	307	30.7%
Nasopharyngitis	56	50	5.0%
Dysmenorrhea	38	35	3.5%
Dizzy	34	33	3.3%
Headache	38	31	3.1%
URI	29	27	2.7%
Oligomenorrhea	27	27	2.7%
Fever	26	25	2.5%
Weak	26	24	2.4%
Nausea	13	12	1.2%
Diarrhea	13	11	1.1%
Muscle pain	14	11	1.1%
Bellyache	12	11	1.1%
Cough	9	8	0.8%
Vomit	6	6	0.6%
Hypersensitivity	4	4	0.4%
Fatigue	6	6	0.6%
Other	277	139	13.9%
Total	2107	685	90.8%

Table 6. Non-vaccination-site AEs related to HPV 9 within 30 days.

Non-vaccination-site	Number of AEs	Number of Subject with one or more AEs	Percentage of Subject with one or more AEs (N = 1000)
Dizzy	9	9	0.9%
Weak	8	8	0.8%
Fever	8	8	0.8%
Nausea	4	4	0.4%
Oligomenorrhea	3	3	0.3%
Fatigue	3	3	0.3%
Muscle pain	2	2	0.2%
Arthrodynia	2	2	0.2%
Pruritus	2	2	0.2%
Thirst	2	1	0.1%
Nasopharyngitis	1	1	0.1%
Headache	1	1	0.1%
Dysmenorrhea	1	1	0.1%
Diarrhea	1	1	0.1%
Bellyache	1	1	0.1%
Amyosthenia	1	1	0.1%
Body unwell	1	1	0.1%
Sweat	1	1	0.1%
Cold	1	1	0.1%
Drowsiness	1	1	0.1%
Shiver	1	1	0.1%
Pharyngitis	1	1	0.1%
Opsomenorrhea	1	1	0.1%
Menorrhagia	1	1	0.1%
Total	57	56	5.6%

Figure 1. Grade of adverse events after HPV9 vaccination.

Table 7. Grade of adverse events after HPV9 vaccination.

	mild	moderate	severe	NA
Vaccination-site	1192	9	0	278
Pain	955	2	0	3
Induration	101	3	0	0
Discomfort	52	0	0	0
Pruritus	12	1	0	0
Hypoaesthesia	10	0	0	0
Swelling	5	0	0	243
Erythema	2	0	0	31
Other	55	3	0	1
Non-vaccination-site	616	11	1	0
Nasopharyngitis	55	1	0	0
Headache	37	1	0	0
Dysmenorrhea	36	2	0	0
Dizzy	34	0	0	0
URI	29	0	0	0
Oligomenorrhea	27	0	0	0
Fever	26	0	0	0
Weak	26	0	0	0
Muscle pain	14	0	0	0
Nausea	13	0	0	0
Diarrhea	13	0	0	0
Bellyache	12	0	0	0
Cough	9	0	0	0
Vomit	6	0	0	0
Fatigue	6	0	0	0
Hypersensitivity	4	0	0	0
Other	269	7	1	0
Total	1808	20	1	278

Figure 2. Duration of adverse events after 9v-HPV vaccination.